Quality Operations Lead - FDA/cGMP Compliance & Team Growth

RXinsider LTD.

Columbus (OH)

On-site

USD 65,000 - 95,000

Full time

14 days+
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Job summary

Safecor Health is seeking a Quality Supervisor in Columbus, Ohio to provide leadership across quality functions, bridging QA and operations to ensure FDA, DEA, and cGMP compliance. You will coach staff, oversee in-process and final inspections, and drive continuous improvement.

You'll collaborate with operations and pharmacists, manage deviations, audits, and regulatory documentation, and support customer audits while maintaining accurate records and labeling accuracy in a fast-paced

Qualifications

  • Bachelor's degree in a science field required.
  • 3+ years in pharmaceutical quality or cGMP environment.
  • Supervisory or lead-level experience preferred.
  • Exposure to FDA/DEA regulations and controlled substances good practice.

Responsibilities

  • Provide daily direction, coaching, and feedback to quality staff.
  • Oversee in-process and final inspections to ensure cGMP compliance.
  • Manage deviations, incident reports, and audits including investigations and closure.
  • Ensure accurate documentation for controlled substances, DEA 222 forms, ARCOS reporting, and labeling.

Skills

Leadership
Quality Assurance
Regulatory Compliance
Training & Coaching

Education

Bachelor's degree in a science-related discipline

Job description

Safecor Health is seeking a Quality Supervisor in Columbus, Ohio to provide leadership across quality functions, bridging QA and operations to ensure FDA, DEA, and cGMP compliance. You will coach staff, oversee in-process and final inspections, and drive continuous improvement.

You'll collaborate with operations and pharmacists, manage deviations, audits, and regulatory documentation, and support customer audits while maintaining accurate records and labeling accuracy in a fast-paced

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