Location: San Francisco Bay Area Company: DiaCarta About DiaCarta: DiaCarta is a leading precision molecular diagnostics company that provides cutting-edge solutions for cancer and infectious disease diagnostics. Our mission is to advance patient care through innovative and accurate diagnostic tests. We are seeking a dynamic and driven Business Development and Account Manager to join our team and drive the growth of our UTI (Urinary Tract Infections) and Oncuria (Bladder cancer test) LDT test offerings, which are covered by MediCare/CMS and private insurances. Position Summary: The Business Development and Account Manager will play a critical role in expanding DiaCarta's presence in the UTI and Oncuria LDT test markets. This position will focus on identifying new business opportunities, building and maintaining relationships with key stakeholders, and driving sales growth in the San Francisco Bay Area. The ideal candidate is a strategic thinker with a passion for sales and a strong understanding of the diagnostics industry. Key Responsibilities:

• Develop and implement business development strategies to drive sales growth for UTI and Oncuria LDT tests.
• Identify and pursue new business opportunities, including potential partnerships, collaborations, and sales channels.
• Build and maintain strong relationships with healthcare providers, laboratories, and other key stakeholders.
• Leverage existing relationships with nursing homes, senior homes, related care specialists, and urologists to promote DiaCarta's products.
• Conduct market research to identify trends, competitive landscape, and customer needs.
• Present and promote DiaCarta's UTI and Oncuria LDT test products to potential clients and partners.
• Collaborate with the marketing team to develop promotional materials and campaigns.
• Monitor and report on sales performance, providing regular updates to senior management.
• Attend industry conferences, trade shows, and networking events to promote DiaCarta's products and services.
• Stay updated on industry developments and regulatory changes affecting the diagnostics market.

Qualifications:

• Proven track record of achieving sales targets and driving business growth.
• Must have existing relationships with nursing homes, senior homes, related care specialists, and urologists.
• Ability to bring in sample and volume business for UTI and Oncuria LDT tests.
• Excellent communication, negotiation, and presentation skills.
• Ability to build and maintain relationships with diverse stakeholders.
• Strategic thinker with strong analytical and problem-solving abilities.
• Self-motivated and able to work independently as well as part of a team.
• Proficiency in Microsoft Office Suite and CRM software.

What We Offer:

• Competitive salary and performance-based incentives.
• Comprehensive benefits package, including health, dental, and vision insurance.
• Opportunity to work with a dynamic and innovative team in a fast-paced environment.
• Professional development and growth opportunities.
• Flexible work arrangements, including the option for full-time, part-time employment or consulting.

Application Process: Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and why they are a good fit for this position.   DiaCarta is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

DiaCarta is a leading translational genomics and personalized diagnostics company. We provide highly sensitive and advanced technologies that will change the landscape of precision medicine and molecular diagnostics by impacting healthcare treatment plans and the well-being of individuals around the world. The DiaCarta Clinical Laboratory is Clinical Laboratory Improvement Amendments (CLIA) certified and qualified for performing high complexity testing. Job Description & Functions

• The CLS is responsible for performance of the daily high complexity laboratory testing procedures on patient samples.  This includes specimen accessioning, sample preparation, analysis, review and reporting of results within the regulated quality management system of the CLIA certified laboratory.
• In addition, the CLS maintains, prepares, and qualifies solutions and reagents used in the laboratory according to protocol.
• Monitors quality control and documents all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
• Demonstrates initiative in making suggestions to improve efficiency and productivity and provides consistent feedback.
• Maintains laboratory in a clean, functional state, as well as cleaning, performing or scheduling equipment and instrument maintenance/calibration/certification, as required.
• Depending on experience, the CLS may validate or direct the validation of new tests in the laboratory; write and reviews procedures, reports; and participate and/ or direct LIMS validations.

Qualifications:

• Licensed in the State of CA to perform high complexity testing (California CLS license) is required.
• 2+ years of equivalent experience (high complexity testing) preferred. General CLS is a plus.
• Ability to perform manual molecular techniques.
• Facility with EXCEL, MSWord.
• Ability to manage daily tasks and work in a fast-paced deadline driven environment.
• Ability to analyze and solve issues that impact test performance.
• Demonstrated ability to understand priorities and work accordingly.
• Demonstrated attention to detail and honest communication regarding errors and misunderstanding.

Schedule:

• Afternoon to night shift preferred, some weekend hours.

  Work Location:

• Pleasanton, CA

DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

A CLA performs laboratory duties under the supervision of a licensed CLS. This position is for assisting the CLS and for sample processing, equipment operation and maintenance, and documents.   Responsibilities:

• Perform sample processing under the supervision of a licensed CLS.
• Follow the instructions, assist the CLS, and perform additional duties and projects as assigned.
• Perform instrument calibrations, maintenance, and operation.
• Receive and accession samples using the laboratory information management system (LIMS).
• Perform data entry and fill all logs.
• Maintain the inventory and assure that all supplies and equipment are adequate to perform the daily functions.
• Ensure laboratory quality control and assurance.
• Maintain a safe laboratory environment in accordance with established standards, protocols, and regulations.
• Ensure compliance with the infection control policies and blood borne pathogen safety precautions.

  Qualification:

• AA degree required; BS/BA in life science is a plus.
• 0-1 year of lab experience.
• Basic computer skills preferred.
• Ability to communicate effectively, both written and oral.
• Ability to manage daily tasks and work in a fast-paced deadline driven environment.
• Strong attention to details.

  Schedule: Different shifts available.   DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Job description: This position is a member of a fast-paced production team and will be responsible for the following tasks.

• Receive raw materials and perform incoming inspection and inventory recording
• Production of DiaCarta IVD products to meet sales demands
• Labeling of raw materials and finished goods
• Compliance with corporate quality systems
• Other on-the-job assignments indicated by management

Requirements:

• High School or above with some working experience in related fields
• Working knowledge of Microsoft Words, Excel, PowerPoint, etc.
• Excellent attention to detail, math, and multi-tasking skills
• Good oral and written communication

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Job Description

• This position is a member of a fast-paced production team and will be responsible for the following tasks.
• Purchase requested materials for all departments.
• Process purchase requisition in the ordering system.
• Keep order records including PO approval, packing list, invoice, etc.
• Perform physical count of materials and plan to replenish inventories.
• Maintain vendor relationships and handle ordering inquiries.
• Participate in process improvement projects.
• Compliance with corporate quality systems.
• Other on-the-job assignments are indicated by management.

  Requirements  

• Associate degree in related field with minimum 1-year industrial experience.
• Working knowledge of Microsoft Word, Excel, PowerPoint, etc.
• Good organization and record-keeping skills.
• Good oral and written communication.

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

We are seeking a highly motivated and experienced Systems Integration Engineer to support ongoing design and development efforts across DiaCarta’s diagnostic platforms. A successful individual in this role will utilize technical knowledge, experience, and engineering tools and methodologies to bridge the gap across functional teams and connect critical elements, including Software, Firmware, Hardware, Consumables, Assays, and Optics.  You will be a critical player in a fast-paced team that is sustaining current generation instrumentation and developing next-generation diagnostic instrument platforms and lab automation systems. This is a new level role to build the Systems Integration team.   Essential Job Responsibilities:

• Collaborates cross-functionally with Biology R&D, Consumables R&D, Software, Technical Support, Service, and other functions to deliver a system-level instrumentation platform that meets the needs of DiaCarta’s Molecular Diagnostics and Oncology product portfolio
• Develops an expert technical understanding of our products and serves as a holistic systems integration engineer capable of hands-on triaging of all DiaCarta systems and subsystems
• Represents Systems Integration function on Core or Extended Project Teams
• Identifies product functionality gaps and collaborates with internal and external teams to support solution implementation
• Leads the characterization of new systems and manages integration activities at the interfaces of firmware, software, consumables, assays, and hardware
• Maintains customer-centric focus, identifies and communicates risks and user pain points throughout the product development process
• Applies sophisticated analytical problem-solving skills to reagent and system integration issues to identify critical performance factors for assay development
• Supports Bio R&D core team in activities related to assay optimization, fluidics development, assay system integration, troubleshooting, and failure analysis
• Supports the optimization of sample preparation, Luminometer, Luminex, real-time PCR and RT-PCR assays on DiaCarta QuantiVirus^TM and QuantiDNA^TM Systems during the development of complex in vitro diagnostic tests
• Leads a cross-functional team to design, test, and validate a new highly spatially multiplexed instrumentation platform, ensuring performance and compatibility with assay products
• Collaborates with System Verification to develop test methods and test plans for system verification and validation activities
• Develops analysis algorithms necessary for efficient and intuitive handling of large combinatoric data sets and works with Software Engineering to implement and test
• Innovates new technologies, algorithms, and methods necessary to advance DiaCarta technology into new market areas such as oncology and genetics
• Maintains internal knowledge base of QuantiVirus^TM and QuantiDNA^TM product hardware, software, consumables, reagent, and fluidic design and performance history as well as the cross-functional implementation of design rules

  MINIMUM REQUIREMENTS:   Education or Experience (in years): 

• Bachelor’s degree with 3+ years of related work experience OR Master’s degree with 2+ years of related work experience OR Doctoral degree with 1+ years related work experience
• Bachelor’s degree or equivalent in a relevant field such as Biology, Biochemistry, Bioengineering, Biomedical Engineering, etc
• Previous experience as a hands-on engineer, scientist, or product developer (e.g. System Integration Engineer, System Development Engineer, or related occupation)
• An advanced degree with practical hands-on experience may substitute for years of industry experience

  Knowledge and skills: 

• Experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, thermal, and firmware components
• Data analysis expertise and experience with various data analysis software packages such as Origin, Matlab, Mathematica, Minitab, JMP, or other
• Well-developed mathematical and statistical analysis skills
• Knowledge of a broad range of principles of biology (including Luminometer, Luminex, real-time PCR and RT-PCR), chemistry, and physics, such as spectroscopic techniques, organic chemistry, electromagnetic theory, and thermodynamics
• Must have strong integration analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems
• Working knowledge of design of experiments, interpretation of test results, failure investigation, and root cause failure analysis
• Excellent communication skills.  Must be able to communicate verbally in an efficient and effective manner and be proficient in written documentation and technical presentations. Must be effective at communication with all levels of employees
• Demonstrated leadership skills including organization and prioritization of complex activities, comfort and effectiveness in providing technical direction to others, and quantitative delivery of team objectives

  PREFERRED REQUIREMENTS (optional):

• Programming experience in C/C++, Python, or other
• Microfluidics expertise
• Medical device and/or in vitroDiagnostic product launch experience
• Understanding of assay product development lifecycle

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.  

DiaCarta is seeking a highly motivated, experienced and interactive Group Leader or Associate Director for liquid biopsy Assay Development to lead one of the key areas in R&D. The new project leader will initiate, direct and execute pre-clinical scientific research and product development activities. The activities will be focused on developing and launching new assay application for IVD cancer diagnostics. The successful candidate will have outstanding attention to detail, enjoy working in a fast-paced multidisciplinary team environment, and have exceptional hands on laboratory skills. The successful candidate should be able to apply a wide variety of scientific principles and concepts to the assay design, assay development and troubleshooting. This is a full-time role in Pleasanton, CA and you will be reporting to the SVP of R&D.   Key Responsibilities:   • Contributes very substantially and intellectually to research and development • Develops new molecular biology assays and optimizes existing assays • Leads projects to create and develop novel nucleic acid based diagnostic tests; including planning, feasibility testing, protocol development, optimization, verification, validation, and launch • Responsible for projects and associated timelines and deliverables • Thoroughly comprehends the objectives and vision of the work • Independently generates, develops and advances new ideas • Independently designs and executes moderate to high complexity experiments • Performs basic data analysis • will manage Scientists and Research Associates • Documents research progress under a Quality Management System • Interacts with on-site CLIA lab, R&D groups, product management, commercial and external collaborators • Communicates progress directly with colleagues and senior managers   Qualifications:  

• Ph.D. in molecular biology or closely related field, or equivalent experience
• Minimum of 3-6 years of industry experience
• Liquid biopsy cancer diagnostics and qPCR or NGS assay development experience are a must
• Experience in IVD assay development is preferred

  Knowledge, Skills and Abilities   • Track record of originating, developing and productizing novel nucleic acid techniques and assays • Proven success in managing collaborative and individual projects, previous experience managing scientists and research associates a plus • Able to provide high level of leadership to Scientists and junior staff • Demonstrated success in applying independent scientific judgment in experimental design and analysis • Experience with nucleic acid technologies relating to multiplex qPCR, digital PCR, NGS and microarrays • Expert in cfDNA, DNA/RNA isolation and purification, qPCR or NGS cancer panel design, assay development and optimization • Very strong analytical and problem-solving skills • Adept with Excel and basic statistical analysis • Bioinformatics skills such as programming (e.g. PERL, python) and datamining are a plus • Skilled at writing clear plans, reports and SOPs • Experience with Design Control is a plus   Physical Demands and Work Environment   • Duties are typically performed in office & laboratory settings (at least 30% of the time in lab) • Standing or sitting for long periods of time may be necessary • Duties may require working outside normal working hours (evenings and weekends) at times   DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Job Description   We’re looking for a results-driven molecular Diagnostic sales representative to actively seek out and engage customer prospects. You will provide complete and appropriate solutions for every customer in order to boost top-line revenue growth, customer acquisition levels, and profitability.   Responsibilities  

• Present, promote, and sell products/services Molecular diagnostic reagents for COVID 19 testing and liquid biopsy for cancer markers.
• Perform cost-benefit and needs analysis of existing/potential customers to meet their needs.
• Establish, develop and maintain positive business and customer relationships.
• Reach out to customer leads through cold calling.
• Expedite the resolution of customer problems and complaints to maximize satisfaction.
• Achieve agreed-upon sales targets and outcomes within schedule.
• Coordinate sales efforts with team members and other departments.
• Analyze the territory/market’s potential, track sales, and status reports.
• Supply management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
• Keep abreast of best practices and promotional trends.
• Continuously improve through feedback.

  Skills  

• Proven work experience as a sales representative selling molecular diagnostic products.
• Rapport with key opinion leaders in the field and established customer knowledge of clinical labs and hospitals.
• Highly motivated and target-driven with a proven track record in sales.
• Excellent selling, communication, and negotiation skills.
• Prioritizing, time management, and organizational skills.
• Ability to create and deliver presentations tailored to the audience's needs.

  Qualifications  

• BS/MS Biotechnology / Premed / Molecular Biology or MBA business administration.
• Past selling experience in molecular diagnostics selling to Clinical Laboratories / Hospitals.

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Job Description   DiaCarta is seeking a highly motivated, independent, and interactive Research Associate to join the R&D function in the company. The new team member will participate in R&D activities with the goal of developing and launching new qPCR, NGS, and branched DNA tests for IVD cancer diagnostics applications. The successful candidate will have outstanding attention to detail, enjoy working in a fast-paced multidisciplinary team environment, and have exceptional hands-on laboratory skills. DiaCarta is a rapidly growing company, so the candidate must be highly motivated and committed to launching their career in an innovative area of molecular diagnostics. This is a full-time role in Richmond, and you will be reporting to the Senior Scientist.   Key Responsibilities  

• Supports the research and development of new tests for DiaCarta’s clinical laboratory and external business partners.
• Carefully plans and executes complex laboratory experiments with excellent attention to detail.
• Performs data analysis with advanced analytical tools and contributes insights toward experimental findings.
• Keeps a detailed laboratory notebook and summarizes work in research reports and meeting presentations.
• Converts newly developed protocols and procedures into SOPs.
• Conducts troubleshooting of laboratory processes and protocols.
• Communicates results with colleagues, R&D management, product management, commercial and external partners.

  Qualifications  

• Sc. degree in molecular biology or a related field and 0-1 years experience in molecular biology laboratory experience, OR
• S. degree in molecular biology or a related field and 0-2 years molecular biology laboratory experience.
• IVD molecular assay development preferred.

  Knowledge, Skills, and Abilities  

• Hands-on experience with PCR techniques including qPCR, multiplex PCR; experience with nucleic acid analysis technologies including Agilent Bioanalyzer, Qubit/Quant-iT, and Nanodrop.
• Experience in IVD assay development preferred.
• Hands-on experience with DNA/RNA isolation and purification, primers design, genomic database mining.
• Hands-on experience with Next Generation Sequencing on Illumina platforms is a plus.
• Possess the ability to think creatively and analytically; very strong analytical and problem-solving skills.
• Proven interpersonal, communication, and presentation skills; excellent time management skills.
• Microsoft Excel experience required.
• Superb attention to detail; produces work of exceptional quality and accuracy.
• Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities.
• Ability to proactively identify issues and address them with the solution-oriented approach.

  Physical Demands and Work Environment  

• Duties are typically performed in laboratory settings (at least 70% of the time).
• Standing or sitting for long periods of time may be necessary.
• Duties may require working outside normal working hours (evenings and weekends) at times.

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Responsibilities   The successful candidate will be a senior member of the companion diagnostics team, reporting to the Team Lead and responsible for a subset of the team deliverables, comprising companion diagnostic technology and product development using biomarkers, qPCR, RT-PCR and NGS, cell-based assays, sample collection and treatment such as liquid biopsy and other techniques, etc.   Senior Scientists are also responsible for proactive communication and collaboration with other teams at the company, such as R&D, Production, QA/QC, Sales/Marketing, etc. The candidate should also be familiar with molecular and cell biology, oncology, genetics and genomics, proteomics, immunology, pharmacology, etc. (including the basic principles, new development trends and applications) and to ensure effective communication, proper alignment of input/output requirements and successful development and integration of the new companion diagnostics to fully support and implementation of precision medicine.   Specific Responsibilities of the Senior Scientist include  

• Design, execution, and oversight of laboratory experiments, in-depth analysis, and reporting of resulting data.
• Literature (including patent) works to support the development of the technology.
• Participation in the integration of the technology into the DiaCarta proprietary platform.
• Generation and management of all required documentation and presentation of results with regulatory guidelines and regulations.

  Person Specification   We are looking for people with drive, enthusiasm, and a strong work ethic who desire to play a key role in the creation of a paradigm shifting platform, that will have a major impact on the health and well-being of patients around the world.   The successful candidate must have the ability to deliver effective solutions to challenging problems in a fast-paced environment with adherence to tight timelines.   The successful candidate must be a team player who interacts well with a variety of colleagues within and outside their area of expertise, manages direct reports effectively, is a strong and proactive communicator, and is willing to step in and take on additional responsibilities as they arise, even those outside the normal scope of responsibilities, in order to help achieve the timely success of the project.   Required Skills & Experience  

• Ph.D. (preferred) in Molecular and Cell Biology or related field.
• Detailed knowledge of chemistries/biochemistry associated with biomarker detections and NGS methods as well as their applications in addressing unmet medical needs.
• Industry experience in the development of molecular diagnostic products and cell-based assays for commercially relevant applications.
• Experience with primary sequence data analysis, including quality metric analysis, from NGS platforms.

  Desirable Skills & Experience  

• 6+ years’ postdoctoral experience in the development of workflows, chemistries, and methods specifically for traditional biomarker detections and NGS. Stronger publications will be helpful to demonstrate past accomplishments.
• Experience interacting with disciplines that may be outside of the candidate's area of expertise, such as engineering, software development, and bioinformatics.
• Experience with nucleic acid amplification (PCR and non-PCR, including isothermal), including clonal amplification methods.
• Industry experience in the development of molecular IVD technology and products for commercially relevant applications.
• Demonstrable creativity and innovation, ideally evidenced by patent filings and relevant publications.

  If you believe you meet the above criteria and would relish playing a key role in developing revolutionary technology, we would be delighted to hear from you.   DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Responsibilities   The successful candidate will be a senior member of the companion diagnostics team, reporting to the Team Lead and responsible for a subset of the team deliverables, comprising companion diagnostic technology and product development using biostatistics, Data analysis, and Data mining for molecular diagnostics and NGS, machine learning and other AI techniques, etc.   Senior Bioinformatics Scientists are also responsible for proactive communication and collaboration with other teams at the company, such as R&D, Production, QA/QC, Sales/Marketing, etc. The candidate should also be familiar with molecular biology, oncology, genetics and genomics, pharmacology, data sciences, programming, computer science, etc. (including the basic principles, new development trends and applications, and required skills and experience in data manipulation and data interpretation) and to ensure effective communication, proper alignment of input/output requirements and successful development and integration of the new companion diagnostics to fully support and implementation of precision medicine.   Specific Responsibilities of the Senior Scientist include  

• Design, execution, and oversight of laboratory experiments and data analysis, in-depth analysis, and reporting of resulting data.
• Literature (including patent) works to support the development of the technology.
• Participation in the integration of the technology into the DiaCarta proprietary platform.
• Generation and management of all required documentation and presentation of results with regulatory guidelines and regulations.

  Person Specification   We are looking for people with drive, enthusiasm, and a strong work ethic who desire to play a key role in the creation of a paradigm-shifting platform, that will have a major impact on the health and well-being of patients around the world.   The successful candidate must have the ability to deliver effective solutions to challenging problems in a fast-paced environment with adherence to tight timelines. The successful candidate must be a team player who interacts well with a variety of colleagues within and outside their area of expertise, manages direct reports effectively, is a strong and proactive communicator, and is willing to step in and take on additional responsibilities as they arise, even those outside the normal scope of responsibilities, in order to help achieve the timely success of the project.   Required Skills & Experience  

• D. (preferred or equivalent) in Molecular Biology or Computer Science or a related field.
• Detailed knowledge of data analysis and manipulation associated with biomarker detections and NGS methods as well as their applications in addressing unmet medical needs.
• Industry experience in the development of molecular diagnostic products for commercially relevant applications.
• Experience with primary sequence data analysis, including quality metric analysis, from NGS platforms.
• Imaging analysis and processing.
• Skillful programmer in python or other developer tools.

  Desirable Skills & Experience   5+ years’ postdoctoral experience in the development of workflows, chemistries, and methods specifically for traditional biomarker detections and NGS. Stronger publications will be helpful to demonstrate past accomplishments.   Experience interacting with disciplines that may be outside of the candidate's area of expertise, such as engineering, software development, and bioinformatics.   Experience with nucleic acid amplification (PCR and non-PCR, including isothermal), including clonal amplification methods.   Industry experience in the development of molecular IVD technology and products for commercially relevant applications.   Demonstrable creativity and innovation, ideally evidenced by patent filings and relevant publications.   If you believe you meet the above criteria and would relish playing a key role in developing revolutionary technology, we would be delighted to hear from you.   DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

This position is a member of a fast-paced production team and will be responsible for the following tasks.

• Purchase raw materials from a vendor
• Receive incoming materials and perform inspection and inventory recording
• Production of DiaCarta IVD products to meet sales demands
• Labeling of raw materials and finished goods
• Perform calibration or preventative maintenance of the instrument
• Participate in process improvement projects
• Compliance with corporate quality systems
• Other on-the-job assignments indicated by management

Requirements

• S. degree in Molecular Biology, Cell Biology, Biotechnology or related field with minimum 1-year industrial experience
• Previous experience working in cGMP environment is a plus.
• Working knowledge of Microsoft Words, Excel, PowerPoint, etc.
• Excellent attention to detail, math, and multi-tasking skills
• Good oral and written communication

  DiaCarta Corporation and all DiaCarta Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

Responsibilities:

• Implements and maintains programs and processes to ensure high-quality products and compliance with cGMP and GLP.
• Primary areas of responsibility include QMS maintenance, Document Control and Document Changes, Trending, Production and R&D Internal Audits, Supplier Qualification and Complaints.
• Contributes to Training, DMR maintenance, tech transfer, batch disposition, labelling approval, deviation and NCR investigations, product and process changes and CMO oversight.
• Reviews manufacturing and equipment logs, and quality control data for in-process and finished products
• Supports inspection management and interacts closely with regulatory agencies.
• Oversees establishment of product specifications., writes and updates SOPs.
• Works extensively with cross-functional teams.
• May lead on investigations of deviations, nonconformances and complaints

Qualifications:

• Bachelor of Science degree with 5+ years’ experience in Quality Assurance
• Knowledge of ISO 13485:2016, 14971:2012 and 21CFR 820.
• Excellent communication, documentation, and organizational skills
• A commitment to continual improvement
• Demonstrates knowledge of MS Office software
• Must have the ability to work effectively under high pressure with multiple deadlines