Manufacturing QA Associate (2nd Shift)

📋 Description

• Use fundamental knowledge of GMP, and established procedures methodologies to provide quality
• Ensure the site performs in a state of compliance by contributing to Quality oversight activities
• Execute real time review of batch documentation and other manufacturing documentation analyzing for
• Support Transfer Master Cell Banks to Manufacturing
• Perform housekeeping and GMP walkthroughs of facility
• Initiate deviations in real-time and assist in investigations

🎯 Requirements

• Bachelor's degree and 2-4 years of relevant experience or a Master's degree and up to 2 years of
• Quality Assurance in GMP facilities, drug substance preferred
• Batch record review, housekeeping monitoring, GMP document review and/or creation
• Reviewing deviation reports, change controls, CAPA, and analytical data
• Experience with Data Integrity
• Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP

🎁 Benefits

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays