Pensacola, FL 32514
Reports to: QA Assurance Manager
Job Summary: The primary purpose of this position is to oversee and coordinate affairs related to QA manufacturing, assure compliance with all FDA cGMP, other relevant regulations, and company SOPs, and to support the cGMP manufacture of products.
- Responsible for direct oversight of the QA Specialist I and QA Specialist II personnel.
- Oversee the label warehouse functions, raw material sampling, packaging component inspection, and contract manufactured finish product inspection.
- Issue and review Manufacturing and Production batch records.
- Responsible for final Batch Record and QC laboratory test sheet review for compliance with cGMPs and SOPs for approval/rejection of finished products.
- Responsible for final review of QC laboratory test sheet and inspection data for release/rejection of raw materials and packaging components.
- Responsible for final review of inspection data for release/rejection of contract manufactured finished product.
- Manage the Reserve Sample Storage system.
- Ensure adequate training and cross training for all direct reports.
- Responsible for review and approval of Returned Goods inspection reports.
- Responsible for creating COAs for finished product when required.
- Responsible for completing annual Mock Product Recall.
- Assist with annual internal audits.
- Monitor operations for compliance to written procedures.
- Work closely with operations management to ensure products of the highest quality are manufactured, packaged, and released.
- Provide cGMP guidance and support to other departments.
- Review and approval of cGMP documents as assigned.
- Education: B.A. Or B.S. Degree in a science related field
- Experience: 3-5yrs Pharmaceutical experience in a cGMP environment. At least 1 year Quality Assurance experience preferred.
- Special skills: Strong verbal and written skills. Attention to detail. Microsoft Word and Excel.
- Travel required in this position: None