Bioassay Analyst
4 weeks ago
Winchester, Massachusetts, United States
Innova Solutions
Full time
Job DescriptionInnova Solutions is seeking a highly skilled Bioassay Analyst to join our team. As a key member of our laboratory operations team, you will be responsible for reviewing and approving cGMP analytical data for release and stability testing from bioassay test methods.
Key Responsibilities:- Review and approval of cGMP analytical data for release and stability testing from bioassay test methods
- Perform data integrity review in support of validation, qualification, and analytical method trending reports
- Support execution of routine Bioassay laboratory operations, including review of logbooks, performance of weekly laboratory housekeeping walkthroughs, preparation of reagents, and cell passaging
- Author and support quality events, including change controls, deviations, CAPAs, OOS investigations, and analytical method performance trend reports
- BS in Cell Biology, Molecular Biology, Biochemistry, or a related discipline with 5+ years industry experience
- Experience in mammalian cell culture and biological methods in one or more of the following areas: immunoassays, cell-based assays, and quantitative PCR methods
- Experience in a GMP/GLP environment is a must
- Experience with statistical analysis software (SoftMax, JMP) preferred
Innova Solutions is a global leader in technology and business transformation solutions. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. Our company values include a commitment to equal employment opportunity and a work environment free of discrimination and harassment.