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Job Requirements of QC Analyst I/II - BioAssay:
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Employment Type:
Contractor
-
Location:
Memphis, TN (Onsite)
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QC Analyst I/II - BioAssay
Careers Integrated Resources Inc
Memphis, TN (Onsite)
Contractor
Job Title: QC Analyst I/II - BioAssay
Job Location: Memphis, TN
Job Duration: 6 Months+
Shift: Monday through Friday 8:00am to 4:30pm (overtime as needed)
Job Description:
- The QC Analyst II role requires strong attention to detail, excellent organizational skills, computer proficiency, and a foundational understanding of laboratory instrumentation. The ideal candidate must also demonstrate effective communication skills and the ability to thrive in a fast-paced, highly technical laboratory environment.
Essential Duties and Responsibilities:
- Perform cell-based immunological in vitro assays (e.g., MLR, cytotoxicity, HLA restriction, CTLp, cell proliferation, etc.) and operate related instrumentation
- Apply knowledge of cGMP/GLP regulations and maintain accurate, compliant documentation to support Quality Control activities
- Review QC test results for accuracy, precision, and compliance, ensuring timely completion of documentation aligned with product release timelines
- Conduct data analysis, including study design, statistical evaluation, and preparation of written and oral reports/presentations
- Record observations and results in trending databases for ongoing analysis and performance monitoring
- Perform aseptic techniques and support mammalian cell culture activities, including maintenance and handling of cell lines
- Support QC operations through inventory management, documentation control, log maintenance, and filing
- Participate in quality improvement initiatives and assist with laboratory investigations, including OOS, CAPA, and related quality events
- Ensure adherence to Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP) to maintain data integrity and traceability
- Perform additional duties as assigned
Qualifications:
- Bachelor’s degree in Biological Sciences or a related field preferred
- 1–2 years of relevant experience in a laboratory, biotech, cell therapy, or related industry; or an equivalent combination of education and experience
- Hands-on experience with aseptic technique and mammalian cell culture required
- Familiarity with cGMP regulations as defined in 21 CFR 210 and 211
- Experience with cell-based assays and molecular biology techniques preferred
- Strong attention to detail with excellent written and verbal communication skills
- Ability to work independently as well as collaboratively within a team environment
- In addition, effective communication skills, and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.
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