Supervisor, Quality Operations

RXinsider LTD.; Columbus (OH); On-site; USD 85,000 - 115,000; Full time

Job summary

Safecor Health is seeking a Quality Supervisor to lead day-to-day quality operations, including inspections, deviations, and controlled substance documentation. You will coach quality staff and partner with operations to ensure production meets FDA, DEA, and cGMP standards.

The role emphasizes accountability, teamwork, and continuous improvement within a fast-paced pharmaceutical environment. Strong leadership and meticulous documentation are essential for success.

Qualifications

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

Responsibilities

• 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.
• 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.
• 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.

Skills

Leadership

Interpersonal skills

Organizational skills

Microsoft Office

SharePoint

Communication

Multitasking

Education

Bachelor's degree in science

Tools

Microsoft Office Suite

SharePoint

Job description

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.