Quality Control, Bioassay Data Reviewer
6 Months
Norwood, MA
Hourly pay- $56
- Must have 5 years QC GMP experience in Data Review
Shift: 11am - 7pm, M-F
Job Summary
In this role, you will support QC Bioassay Labs with review of test records and documents.
Job Responsibilities
- Review executed QC test records for molecular and cell based assays
- Review Audit trails
- Review reagent and equipment logbooks
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Additional duties may be assigned.
Education & Qualifications
- STEM degree with 5 years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)
- Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
- Previous experience using Labvantage LIMS and LES worksheets
- Excellent communication skills (verbal and written)
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Experience with laboratory information systems
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of Data Integrity principles and Good Documentation Practices
