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Quality Assurance Associate
2 months ago
The primary responsibility of this position is to ensure the quality and integrity of our products by overseeing the release and approval of completed documentation for batch folders following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). As a Quality Assurance Associate, you will be accountable for quality oversight on the floor, responsible for trending of observations from the floor to improve them, and accountable for manufacture support activities on the floor, revising Standard Operating Procedures (SOPs) and forms, and developing training.
Key Responsibilities- Responsible for raw material and bulk container receipts, release, and investigation if any issues found. Follow-up with appropriate facilities for documentation correction.
- Manufacturing support activities including batch record documentation, issuance of Batch record, approval of OSI PI Reports, scanner card delivery of test and stability samples, label copy control and issuance, raw material release, in-process work order release, and retain sample management.
- Responsible for oversight of quality line operations concerning product quality and conformance to regulations and company quality procedures.
- Quality Approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
- Identify and assess quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. Responsible for TIQ/QOTSF program management.
- Develop training materials and procedures and participation on cross-functional teams to implement process improvements. Be a Subject Matter Expert (SME) and provide training to employees needed on relevant areas.
- Demonstrate effectiveness in task completion and empowerment of others, deviation/nonconformance management, training, and problem-solving.
- Complete interfacility impact assessments for product/process changes.
- Manage root cause investigations, close deviations, assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
- Participate in internal and external regulatory audits as a SME for Quality operations and present to auditor.
- Typically requires a bachelor's degree in science, engineering, or other related technical field. Some related experience.
- Knowledge of the local and international regulatory environment and regulations for manufacture of biological products.
- Analytical and problem-solving skills.
- Acts as a change agent to sufficiently motivate team members to achieve team goals.
- You must not be allergic to Cephalosporin drugs.
- Ability to walk 1-3 miles and lift 10 lbs. during a workday is required.
- Indoor working conditions.
