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