Title: QC Data Review
Location: Norwood, MA
Interview Process: 1 hour panel on-site interview with the team
Shift: MON - FRI, 11AM - 7PM
Duration: 6 Months with potential to flip
The Role
In this role, you will support QC Bioassay Labs with review of test records and documents.
This is an on-site position. The shift is Monday to Friday, 11 am to 7pm.
Here's What You'll Do
- 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.
Here's What You'll Need (Basic Qualifications)
- Education: BA/BS Degree
- Experience: 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)
Here's What You'll Bring to the Table (Preferred Qualifications)
- 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
- 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