Manufacturing Quality Assurance Manager, Direct Hire
Job requisition #6358
Greater Chicago Area
Description of Manufacturing Quality Assurance Manager
Responsible for the management of the Manufacturing Quality Assurance department including managing the evaluation, implementation, execution and follow-up on quality systems to ensure GMP compliance and release of finished product. Quality oversight of the manufacturing and packaging processes and procedures allowing for the accurate and timely release of manufacturing and packaging batch record documentation.
This Manager provides final review of investigations to ensure product quality and implementation of corrective actions to prevent recurrence. Analyzes quality and manufacturing indicating data and recommends actions for compliance and process improvement.
Responsibilities for Manufacturing Quality Assurance Manager
- Lead a team of Manufacturing QA Supervisors and Specialists in daily integration of monitoring, auditing and review of pharmaceutical manufacturing operations.
- Provide compliance direction to all manufacturing groups including packaging, MQA and other quality support groups.
- Evaluates existing onsite quality systems and recommends, develops, secures approval of, implements and follows up on new and existing quality systems.
- Designs, implements and monitors performance of daily quality assurance audit function, in-process quality check and batch record review.
- Troubleshoots manufacturing and quality issues and forms corrective action plans to resolve issues.
- Troubleshoots and monitors performance of quality assurance personnel including:
- Reviewing production deviations and environmental excursions.
- Evaluation of action plans.
- Review of protocols for process and equipment enhancements.
- Conducting manufacturing process audits, issuing batch records, Performing labeling and functionality checks, Executinginspection program, including qualifications, AQL executions and defect categorizations.
- Auditing completed batch records prior to product release.
- Performing daily quality oversight of production with focus on critical process steps.
- Trending/analyzing process data and supporting Quality in inspections for the Manufacturing facility.
- Effectively hires, develops, coaches, manages and motivates staff.
- Identifies and implements needed organizational changes to meet operational plans, QA goals and objectives.
- Develops and administers financial budget for the department.
- Manages work in process to facilitate timely release of finished product meeting GMP requirements.
- Releases product that demonstrate compliance to GMP requirements through review of manufacturing and testing documentation.
- Investigates product not meeting specifications prior to release and/or rejection.
- Advises the Director, QA on daily operations. Makes/implements recommendations for improvement.
Requirements for Manufacturing Quality Assurance Manager
- Bachelor of Science Degree
- 5+ years of supervisory/management experience in quality supporting pharmaceutical manufacturing processes.
- Experience working and supporting quality on the manufacturing floor.
- Extensive knowledge of legal and regulatory requirements governing the manufacture of pharmaceuticals.
- Technical knowledge of pharmaceutical manufacturing related processes, process and equipment validation preferred.