The position will perform general QA work in a GMP Pharmaceutical manufacturing site, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations.
- Evaluation of batch manufacturing records and testing records
- Initiate and investigate complaints
- Authority to approve written procedures and other documents
- Develop Standard Operating Procedures and other quality related documents.
- Investigate/Approve on deviations and/or preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
- Author/review change control documents for compliance
- Interact with plant personnel to insure CGMP compliance.
- Working knowledge of US Drug Product GMP requirements and associated guidelines.
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Ability to increase others knowledge of US end European GMP regulations and guidance.
- Minimum of 3 years of Quality Assurance or Manufacturing experience in the pharmaceutical industry
- Bachelor’s degree in a scientific discipline or equivalent.
Phone: 860-278-5840 ext 245