Quality Control, Bioassay Data Reviewer
4 days ago
Quality Control, Bioassay Data Reviewer
6 Month Initial Contract | Norwood, MA
Hours: 11am - 7pm Mon-Fri
*Can submit above the stated pay rate*
The Quality Control, Bioassay Data Reviewer will support QC Bioassay Labs with review of test records and documents.
MUST HAVE (no exceptions)
- Must have 5 years QC GMP / Data Review experience
- Will be responsible for reviewing release data (a big responsibility) as this is used to release the product to the market
- Critical eye for minor details & strong grasp of what they are reviewing
- Example: Sequencing, PCR, qPCR, ELISA, Western Blot, gel electrophoresis
- Background in Molecular Biology
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
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