Description

Provide QA operational support within GMP manufacturing suites during the second shift.

You will own batch record reviews, deviation investigations, and compliance documentation.

Responsibilities

• Initiate investigations for product deviations and non-conformance issues.
• Assist with CAPA development, and review or 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.
• Review environmental monitoring trend reports and generate summaries.

Required Skills

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

Key Skills

Education

Bachelor's degree