Laboratory Quality Assurance Associate I
2 weeks ago
Invivoscribe is a leader in the field of precision diagnostics, committed to enhancing patient outcomes through innovative testing solutions. With over 25 years of experience, we have established ourselves as a global authority in standardizing diagnostic testing and facilitating access to advanced cancer therapies.
Our headquarters in San Diego, California, along with our international presence, allows us to provide a wide range of products and services. We collaborate with industry partners to create molecular assays, reagents, controls, and bioinformatics tools that adhere to ISO 13485 design controls, utilized by over 700 clinical laboratories in more than 160 countries.
Our extensive laboratory network delivers internationally standardized next-generation molecular and flow cytometry panels, supporting drug development and expediting regulatory approvals globally. We work closely with pharmaceutical companies and regulatory bodies to develop companion diagnostics essential for the approval of new cancer treatments. Our ISO15189 accredited and CLIA/CAP certified laboratories focus on clinically actionable biomarkers, aiding in therapeutic decision-making, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all aimed at accelerating the approval of innovative oncology drugs.
We are seeking a Quality Control Laboratory Associate I / II to join our Quality Control Team.
The primary responsibility of the Quality Control Laboratory Associate I or II is to ensure that products are rigorously tested to comply with applicable regulations and industry standards. The Quality Control Laboratory Associate II will also support investigations, stability studies, projects, Field Actions, post-market surveillance, statistical quality control activities, and the maintenance of a GMP environment. This role will involve addressing customer inquiries and complaints.
Key Responsibilities:
- Quality Control Laboratory Associate I:
- Maintain and uphold Standard Operating Procedures (SOP) and acceptance criteria for departmental and product testing.
- Conduct thorough testing of raw materials, in-process samples, and final products, generating accurate testing data.
- Execute and oversee real-time stability study testing.
- Manage inventory of materials utilized in quality control processes.
- Compile and maintain QC-related data in a comprehensive database.
- Quality Control Laboratory Associate II:
- Assist with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validation processes.
- Support troubleshooting efforts and root cause analysis.
- Document and address product inquiries and complaints, including analysis and troubleshooting.
- Review records for accuracy and completeness.
- Contribute to post-market surveillance and Field Action Assessments (FAAs).
- Oversee Quality Control reagent inventory, including electronic transactions and adjustments.
- Engage in statistical quality control activities.
Qualifications:
- B.S. degree in a scientifically related field with 0-2 years of experience for Quality Control Laboratory Associate I or 2+ years for Quality Control Laboratory Associate II in a GMP regulated environment, or an equivalent combination of education and experience.
- Familiarity with techniques such as polymerase chain reactions, gel electrophoresis, capillary electrophoresis, next-generation sequencing, DNA/RNA isolation and purification, and cDNA synthesis is preferred.
- Knowledge of medical device quality and regulatory requirements, including QSR and ISO quality system standards, is advantageous.
- Experience with equipment such as 3500xl Dx, ABI 7500 Dx, PGM Dx, S5 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, LabChip Gx, NanoDrop Spectrophotometer, iBright, and pipetting devices is preferred.
- Proficient in computer skills with a strong command of Microsoft Office programs (Word, Outlook, Excel, PowerPoint) and the ability to learn new software, including Adobe Acrobat, Illustrator, and/or Photoshop. Familiarity with JMP, Oracle Cloud, or other ERP systems is beneficial.
What We Offer:
- A modern facility that supports a hybrid work-from-home arrangement.
- A diverse and inclusive workplace where professional growth and collaboration are encouraged.
- A well-stocked breakroom with a variety of refreshments and snacks.
- Competitive salaries, a bonus program, comprehensive benefits, a 401k plan with employer match, and generous time-off policies.
Invivoscribe is an Equal Opportunity Employer.
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