Description

You will provide QA operational support within GMP manufacturing suites during the second shift.

Responsibilities

• Initiate investigations resulting from product deviations and non-conformance issues.
• Assist with the development of CAPAs and review/approve deviations.
• Review and approve executed batch records, raw data, sample test results, Final Reports, and CoAs.
• Perform visual inspections and observe production processes and staff within manufacturing suites.
• Review environmental monitoring trend reports and generate environmental summaries.

Required Skills

• 2+ years of experience in a QA, QC, or Manufacturing role.
• Bachelor's degree or Associate degree.
• Experience working in a life science, pharmaceutical, or medical products GMP environment.
• Direct experience with batch record review.
• Experience reviewing and approving deviations or investigations.
• Proficiency using LIMS, QMS, or other databases for documentation and SOP review in a paperless environment.
• Working knowledge of SAP, eLIMS, Novatek, or Master Control.

Key Skills

Education

Bachelor's degree