The QA Specialist will provide Quality Assurance (QA) support for GMP manufacturing, focusing on the production of master/working cell banks, biological bulk drug substances, and finished drug products. The role requires providing QA oversight of manufacturing processes to ensure compliance with regulatory and industry standards for the GMP manufacture of biological products.
Key Responsibilities:
- Provide 75% on-the-floor QA oversight for GMP operations in the manufacturing of cell banks, bulk drug substances, and final drug products.
- Perform QA support for client projects, including room release, real-time batch documentation review, logbook review, and critical process observation.
- Collaborate with Manufacturing and support teams to resolve manufacturing issues and ensure compliance.
- Conduct Acceptable Quality Limit (AQL) visual inspections of drug products.
- Review and approve batch documents for media and buffer preparation solutions.
- Generate or revise GMP documentation such as SOPs, Master Batch Records, and SMPs.
- Compile deviations observed during manufacturing and ensure timely completion.
- Conduct audits of manufacturing and support areas, ensuring adherence to internal procedures and Good Documentation Practices (GDP).
- Make quality decisions independently with limited oversight.
- Participate in site-wide quality and process improvement initiatives.
- Provide guidance on cGMP compliance, regulatory requirements, and industry best practices.
- Engage in individual training and manage personal training plans.
- Other duties as assigned.
Position Requirements:
Education:
- Master’s degree in a Scientific, Engineering, or Biotech field with 0-2 years of experience in QA/QC/Manufacturing, or
- Bachelor’s degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in QA/QC/Manufacturing.
Experience:
- Familiarity with GMPs, 21 CFR Parts 210, 211, biological regulations (21 CFR Parts 600s), ICH Guidelines, and EU GMPs.
- Knowledge of biological manufacturing processes such as cell banking, fermentation/cell culture, purification, and fill/finish.
- Familiarity with electronic systems like LIMS, MasterControl, and Track wise.
- Ability to apply basic scientific and regulatory principles to solve quality tasks.
Skills:
- Strong analytical, troubleshooting, and decision-making skills.
- Ability to learn and adapt to new manufacturing processes.
- Proficient in Microsoft Office and able to produce reports.
- Team-oriented and able to work independently under supervision.
- Ability to deliver results in a fast-paced environment with strict client deadlines.