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Laboratory Quality Assurance Specialist I
2 months ago
Invivoscribe is a leading organization committed to enhancing lives through Precision Diagnostics. With over 25 years of experience, we have been at the forefront of international standardization in testing, facilitating patient access to cutting-edge cancer treatments.
Our headquarters is located in San Diego, California, and we operate globally, providing a diverse range of products and services. We collaborate with key partners to develop molecular assays, reagents, controls, and bioinformatics tools under ISO 13485 design control, utilized by over 700 clinical laboratories in more than 160 countries.
Our extensive network of laboratories delivers internationally standardized next-generation molecular and flow cytometry panels, supporting drug development and expediting drug approvals worldwide. We partner with pharmaceutical companies and international regulatory bodies to create companion diagnostics essential for the approval of new cancer therapies. Our ISO15189 accredited and CLIA/CAP clinical laboratories focus on biomarkers that are clinically actionable, facilitating therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all aimed at accelerating the approval of new oncology treatments.
We are seeking a Quality Control Laboratory Associate I / II to join our Quality Control Team.
The role of the Quality Control Laboratory Associate I or II involves ensuring that products are tested in compliance with applicable government regulations and industry standards. The Quality Control Laboratory Associate II also plays a crucial role in assisting with investigations, stability studies, projects, Field Actions, post-market surveillance, statistical quality control activities, and maintaining a GMP environment. Additionally, this position addresses customer inquiries and complaints.
Key Responsibilities:
Quality Control Laboratory Associate I:
- Maintain Standard Operating Procedures (SOP) and acceptance criteria for departmental and product testing.
- Conduct testing of raw materials, in-process samples, and final products, generating accurate testing data.
- Oversee and conduct real-time stability study testing.
- Manage inventory of materials utilized in quality control.
- Compile QC-related data and maintain comprehensive databases.
Quality Control Laboratory Associate II:
- Assist with Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validations.
- Support troubleshooting and root cause analysis efforts.
- Document and address product inquiries and complaints, including analysis and troubleshooting.
- Review records for accuracy and completeness.
- Participate in post-market surveillance and Field Action Assessments (FAAs).
- Maintain inventory of Quality Control reagents, executing electronic transactions and adjustments.
- Contribute to statistical quality control activities.
Qualifications:
- B.S. degree in a relevant scientific field with 0-2 years of experience for Quality Control Associate I or 2+ years for Quality Control 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.
- Understanding 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 pipettes is preferred.
- Proficient in computer skills, with a strong working knowledge of Microsoft Office applications (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 with flexible work arrangements.
- A diverse and inclusive workplace that fosters learning and growth.
- A well-stocked breakroom with refreshments and snacks.
- Competitive salaries, bonus programs, comprehensive benefits, a 401k plan with employer match, and generous time-off policies.
Invivoscribe is an Equal Opportunity Employer.
