QC Virology Analyst

Role Summary

QC Virology Analyst responsible for routine testing to detect adventitious agents, ensure timely test results release to manufacturing, and maintain compliant laboratory operations on a 1st shift (Monday–Friday, 8:00 am–4:30 pm).

Responsibilities

• Perform routine testing for adventitious agents using molecular and cell-based assays for in-process commercial and clinical products.
• Review testing data for conformance with cGMP and assist with investigations of laboratory and/or process deviations.
• Receive samples from manufacturing and maintain mammalian cell lines to support cell-based assays.
• Assist with laboratory maintenance (e.g., equipment cleaning) and administrative tasks related to testing or the Viral Safety program.
• Ensure laboratory compliance and perform weekly checks to uphold good laboratory practices (e.g., discard expired materials, maintain documentation).
• Maintain a safe, clean, and compliant working environment for self and others.
• May run experiments to support method development and/or validation.

Qualifications

• Required: BS/BA in Cell Biology, Microbiology, Biochemistry, or related Life Science; or an equivalent combination of education and experience.
• Associate QC Analyst: BS/BA in Cell Biology, Microbiology, Biochemistry or related Life Science; or an equivalent combination of education and experience.
• QC Analyst: 12‚Äì18+ months of related experience; or an equivalent combination of education and experience.

Skills

• Experience with mammalian cell culture, aseptic technique, and In Vitro and/or PCR.
• Structured, routine work style with ability to handle competing priorities and participate in projects beyond routine lab work.
• Problem-solving abilities and capability to apply troubleshooting methods; data gathering and trending to support testing and investigations.
• Willingness to wear appropriate PPE and work under Biological Safety Cabinet and Microscope.

Education

• BS/BA in Cell Biology, Microbiology, Biochemistry or related Life Science; or an equivalent combination of education and experience.

Additional Requirements

• Gowning and Environment: cleanroom attire required; remove jewelry, makeup, and nail adornments when in cleanroom attire.
• Shift & Physical Requirements: ability to perform physical requirements for up to 10 hours per shift; may include bending, climbing, crawling, kneeling, reaching, sitting, standing, driving, and lifting/pushing/pulling up to 20 lbs.
• Travel: none specified.