Senior Quality Assurance Associate

Safecor HealthColumbus, OH
110d

About The Position

At Safecor Health, we're not just repackaging medications, we're redefining pharmaceutical services with Care, Commitment, and Excellence at the heart of everything we do. Our Quality Assurance team plays a vital role in ensuring that the medications trusted by patients and providers are handled with the highest standards of safety and compliance. We're looking for a Senior Quality Assurance Associate who is passionate about quality, thrives in a regulated environment, and wants to contribute to meaningful work that impacts healthcare nationwide.

Requirements

  • Bachelor's degree in chemistry, life sciences, or related field (or equivalent experience).
  • 3-5 years in pharmaceutical Quality Assurance or Quality Control, including lab experience.
  • Familiarity with FDA regulations, cGMP practices, and use of laboratory equipment such as HPLC and GC.
  • Experience with Master Control or similar systems is a plus.
  • Detail-oriented, highly organized, and able to balance independent work with strong team collaboration.
  • Skilled in documentation, communication, and problem-solving.

Responsibilities

  • Support Quality Systems & Compliance: Help maintain FDA-compliant systems (21 CFR Parts 210 & 211), DEA requirements, and state licensing standards.
  • Be a Stability Studies Expert: Create protocols, coordinate testing, review results, and investigate OOS findings.
  • Lead as a System SME: Use your expertise in Stability LIMS (SLIMS) and Master Control to manage documentation, supplier communication, and recordkeeping.
  • Hands-On Oversight: Perform shop floor checks, review batch records, and support inspections of raw materials, finished goods, and labeling.
  • Drive Documentation Excellence: Draft, review, and maintain SOPs, forms, and training records.
  • Support Audits & Inspections: Participate in internal audits and help prepare for FDA, DEA, and third-party inspections.
  • Promote Continuous Improvement: Track deviations, CAPAs, and metrics while collaborating across teams to strengthen quality and efficiency.

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What This Job Offers

Career Level

Mid Level

Industry

Merchant Wholesalers, Nondurable Goods

Education Level

Bachelor's degree

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