Quality Assurance Specialist

2 hours ago


New Albany, Ohio, United States Wedgewood Village Pharmacy, LLC Full time
Quality Assurance Role

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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