Supervisor, Quality Operations

Posted 3 Days Ago
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43204, Columbus, OH, USA
In-Office
Mid level
Healthtech • Pharmaceutical
The Role
Supervise quality operations for pharmaceutical packaging, including inspections, deviations, audits, controlled-substance documentation, labeling, and regulatory compliance. Lead and coach quality staff, support FDA and customer inspections, coordinate with operations and pharmacists, and ensure adherence to FDA, DEA, OSHA, cGMP, and company standards.
Summary Generated by Built In

At Safecor Health, our values of Care, Commitment, and Excellence guide everything we do. We care about the patients and healthcare providers who rely on us, we are committed to maintaining the highest standards of quality and compliance, and we pursue excellence in every detail of our operations.

We are seeking a Quality Supervisor to provide leadership, oversight, and guidance across Safecor Health’s quality functions. This role bridges quality assurance and operations, ensuring compliance with FDA, DEA, and cGMP requirements while fostering a culture of accountability, teamwork, and continuous improvement.

Job Summary

The Quality Supervisor is responsible for overseeing day-to-day quality operations, including in-process and final product inspections, deviation and audit management, and controlled substance documentation. This role will lead, coach, and develop quality staff, while also working cross-functionally with operations to ensure that all production processes meet regulatory and company standards.

Key Responsibilities

Leadership & Supervision

  • Provide daily direction, coaching, and feedback to quality staff, fostering professional growth and accountability.
  • Train and mentor new employees on quality procedures, compliance, and best practices.
  • Promote a safe, compliant, and inclusive environment, ensuring adherence to OSHA and company safety requirements.

Quality Assurance & Compliance

  • Oversee in-process and final inspections to ensure products meet quality specifications and cGMP requirements.
  • Manage deviations, incident reports, and audits - including investigation, documentation, and closure.
  • Ensure accurate documentation and recordkeeping for all controlled substances, DEA 222 forms, ARCOS reporting, and product destruction activities.
  • Support regulatory inspections and customer audits with professionalism and thorough preparation.
  • Ensure labeling accuracy and oversee creation and revision of drug and packaging labels.

Cross-Functional Collaboration

  • Partner with operations supervisors and pharmacists to align on production and quality goals.
  • Work closely with operations to ensure inspection procedures are implemented, documented, and maintained.
  • Serve as a point of contact for drug manufacturers to gather product-specific information.
  • Facilitate clear, timely, and concise communication across teams and with customers.
Qualifications

Education & Experience

  • Bachelor’s degree in a science-related discipline required.
  • 3+ years of pharmaceutical industry experience or equivalent cGMP experience in quality.
  • Supervisory or lead-level experience preferred.
  • Quality experience within an FDA-regulated facility required.
  • Experience with controlled substance regulations and repackaging medications is strongly preferred.

Knowledge, Skills & Abilities

  • Strong leadership and interpersonal skills with the ability to motivate and coach a team.
  • In-depth knowledge of FDA, DEA, and cGMP requirements for pharmaceutical operations.
  • Excellent organizational skills; detail-oriented, accurate, and efficient.
  • Effective communicator, both verbal and written, with the ability to collaborate across departments.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and SharePoint.
  • Ability to manage multiple priorities and deadlines in a fast-paced environment.

Why Join Safecor Health?

  • Care: Work in a supportive environment where your leadership ensures patients receive safe, high-quality medications.
  • Commitment: Be part of a team dedicated to compliance, collaboration, and continuous improvement.
  • Excellence: Lead a group that takes pride in delivering quality every single day.

At Safecor Health, your leadership in quality will make a direct impact on healthcare and help us continue setting the standard in pharmaceutical packaging.

Skills Required

  • Bachelor's degree in a science-related discipline
  • At least 3 years of pharmaceutical industry experience or equivalent cGMP quality experience
  • Quality experience within an FDA-regulated facility
  • Supervisory or lead-level experience
  • Experience with controlled substance regulations
  • Experience repackaging medications
  • Knowledge of FDA, DEA, and cGMP requirements for pharmaceutical operations
  • Proficiency with Microsoft Office Suite and SharePoint
  • Strong leadership, communication, organization, and multitasking skills
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The Company
HQ: Columbus, OH
87 Employees

What We Do

We all know someone who's been in the hospital -- a parent, spouse, child, neighbor, coworker or friend. Safecor Health helps hospitals ensure quality and patient safety through superior packaging and bar coding services. Safecor Health is the industry leader committed to providing institutional pharmacists with unit-dose repackaging services that allow them to outsource the challenging and time-consuming tasks of packaging. Operating out of two state-of-the-art, FDA-registered facilities, Safecor Health helps pharmacies develop a comprehensive unit-dose packaging strategy. Repackaging services include: - Unit-dose oral solids - Liquid unit-dose cups - Oral syringes - Robot-compatible packaging - Controlled substance packaging - Hazardous drug packaging - Bar coding and labeling Safecor Health's services provide significant cost savings and operational efficiency to more than 1,000 hospitals and health systems nationwide, all while improving quality, patient care and medication safety. Learn more at safecorhealth.com.

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