Review of Batch Records and other documentation in support of final product disposition
Perform batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained
Assure that the finished product is not released until the appropriate release testing and batch record review has been performed
Initiate, lead, and act as SME for change controls.
Review finished product and batch documentation and check against the registered specifications
Assure cGMP's and company procedures are followed and, if needed, procedures/policies are revised
Assist in deviation/nonconformance identification and resolution.
Participate and/or help lead root cause analysis to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution.
You will partner with manufacturing personnel and other departments as needed, to resolve issues on the manufacturing floor
Drafting and processing quality agreements with CMOs and contract testing labs
Participate in internal and external meetings, Business Review Meetings, and site audits to ensure GMP & GLP compliance
Qualifications:
Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline.
5+ years of QA experience within biopharma/biotech
Clean room environment experience preferred
Experience in FDA, GMP, and GLP regulations
Experience with Continuous improvement, Six Sigma, and/or Lean principles is desired
Knowledge of QMS (TrackWise/Veeva), ERP systems, and electronic batch records