Quality Assurance Specialist
2 hours ago
At Wedgewood Village Pharmacy, LLC, we are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our pharmaceutical products. This includes performing quality activities in a sterile pharmaceutical manufacturing facility, understanding pharmaceutical cGMP requirements, and maintaining document control through review, approval, and issuance of SOPs, batch records, labels, and other controlled documents.
Key Responsibilities
- Release all components, drug product containers, closures, packaging, labeling, in-process materials, and finished products.
- Monitor storage conditions of the manufacturing environment, materials, and products.
- Review and retain all records associated with batch issuance, work instructions, release of product, and all quality management data.
- Review laboratory data of the finished drug product, environmental monitoring, microbiological testing, chemical testing, in-process testing, and stability testing.
- Identify adverse trends and recommend improvements.
- Communicate with Production and Shipping/Receiving to ensure appropriate materials and supplies inventory are appropriately qualified, documented, and suitable for intended use in manufacturing.
- Investigate, review, and trend deviations, OOS results, and customer complaints.
- Support equipment calibration, equipment/utility/facility validation, and preventive maintenance.
- Participate in reviews of process qualification and product quality.
- Manual QMS, including document control of SOPs, batch records, controlled documents, training module, and all quality activities.
Requirements
- Excellent written, verbal communication, and presentation skills.
- Ability to adapt to changing priorities and circumstances.
- Ability to think and act independently while knowing when to include others in decisions.
- Ability to work in a dynamic, fast-paced, and timeline-driven environment with shifting priorities.
- Strong understanding of Microsoft Office and Excel software.
- Experience in investigating and writing customer complaints.
- Strong problem-solving and decision-making skills.
What We Offer
- A comprehensive benefits package that includes health, dental, and flexible spending accounts.
- 401(k) retirement plan with a generous company contribution to help you save for the future.
- Company-paid life and disability insurance.
- Access to voluntary insurance options.
- A generous paid time off program that increases every year.
- Tuition reimbursement.
- Opportunity for growth - We believe in promoting from within and do so through our internal job posting program.
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