Bioassay QC Analyst: GMP Data & Cell Assays (Onsite)

Innova Solutions Inc; Woburn (MA); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Medical & pharmacy coverage

Dental/vision insurance

401(k)

Health savings account (HSA) and FSA

Job summary

Innova Solutions has a client that is immediately hiring for Analyst, Bioassay/ QC Analyst. Location: Woburn, MA onsite.

This Fulltime - Contract role involves reviewing and approving cGMP analytical data for release and stability testing from bioassay methods including ELISA and cell-based assays. You will support routine Bioassay lab operations, perform data integrity reviews, author quality events and trend reports in a GMP/GLP environment.

Qualifications

• 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
• Ability and desire to work in a fast-paced environment
• Strong collaboration, team-working skills, and communication skills
• Independently motivated and detail-oriented with good problem-solving ability
• Strong communication, interpersonal and organizational skills

Responsibilities

• Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
• Perform data integrity review (i.e. data verification) in support of validation, qualification, and analytical method trending reports, as needed
• Support execution of routine Bioassay laboratory operations including, but not limited to: Review of logbooks (reagent preparation, equipment, critical reagent tracking), Performance of weekly laboratory housekeeping walkthroughs, Preparation of reagents, Cell Passaging
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Author analytical method performance trend reports, as needed.

Skills

Experience in mammalian cell culture

GMP/GLP environment

Statistical analysis software (SoftMax

JMP

Education

BS in Cell Biology, Molecular Biology, Biochemistry or related discipline

Tools

SoftMax

JMP

Job description

Innova Solutions has a client that is immediately hiring for Analyst, Bioassay/ QC Analyst. Location: Woburn, MA onsite.

This Fulltime - Contract role involves reviewing and approving cGMP analytical data for release and stability testing from bioassay methods including ELISA and cell-based assays. You will support routine Bioassay lab operations, perform data integrity reviews, author quality events and trend reports in a GMP/GLP environment.