Quality Assurance Supervisor

Fagron Nederland BV; Canton, Northern (MA, KY); Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision & dental insurance

Health Savings Account (HSA)

Job summary

Fagron US seeks a Quality Assurance Supervisor to lead QA activities for cGMP manufacturing, documentation, and product disposition. You will manage a team, ensure ALCOA-compliant records, and support audits and change controls.

The role emphasizes leadership, quality systems, and rapid decision-making to maintain compliance across manufacturing, packaging, and warehousing of compounded products.

Qualifications

• College degree required and >10 years of cGMP experience in pharma manufacturing or equivalent.
• Experience with quality systems, aseptic technique, cGMP document review, investigations, CAPA, Change Control, MasterControl preferred.
• Proficient in MS Office (Word, Excel).
• Ability to process information rapidly from multiple sources and communicate effectively.
• Ability to manage high workload and adapt to changing environment.

Responsibilities

• Coach and lead direct reports in Level 1–3 QA tasks and ensure proficiency.
• Lead QA documentation controls, batch records, and review/approval processes.
• Oversee change controls, event reports, and corrective actions.
• Support audits and inspections (internal, corporate, 3rd party, and regulatory).
• Ensure cGMP documentation meets ALCOA standards.

Skills

Leadership

Quality Assurance

Document Review

CAPA

Communication

Education

College Degree

Tools

MasterControl

MS Office

Job description

About the Job

The Quality Assurance Supervisor is a leadership level position that has direct reports and is responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition or compliance and quality systems. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products. Or, ensures that site quality systems are operating as intended meeting compliance requirements.

Key Responsibilities

• Coach and facilitate direct reports’ proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks:
• Level 1:
  • Manufacturing / Packaging Line Clearances
  • Product Label Review and Approval
  • Product Label Reconciliation
  • EMS Data Review
  • Logbook Review and reconciliation
• Level 2:
  • Batch Record Issuance
  • Batch Record Review and Approval
  • Incoming Material Review and Approval
  • Form and Logbook Issuance
  • Review and Approval of Testing Data
  • Review and Approval of Event Reports and Associated Corrective Actions
• Level 3:
  • Disposition and Release of Incoming Materials
  • Disposition and Release of Finished Product
  • Document Control Activities
  • Review and Approval of Change Controls and controlled document changes
  • Review and Approval of Moderate Risk Deviations
• Will have a min of three and a max of seven direct reports at the QA Generalist, Specialist, or Officer levels.
• Completes administrative leadership tasks including, but not limited to task scheduling, KPI tracking, and individual performance monitoring.
• Demonstrated Subject Matter Expertise or ability to develop expertise in QA responsibilities relevant to assigned QA group (e.g. MQA, QS and Compliance, or other.)
• Takes on QA projects of low to high complexity as assigned.
• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Provide QA and compliance guidance and decision making for all manufacturing functions.
• Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Lead or assist with problem identification and resolution efforts for quality related issues associated with compounding operations.
• Lead or assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Lead compilation and analysis of information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
• Ensure cGMP documentation associated with work activities meets ALCOA standards.
• Maintain assigned training standard operating procedures. Monitor training requirements of direct reports.
• Perform other related duties as assigned.

Basic Qualifications

• College Degree and greater than ten years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience is required.
• Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to process information rapidly from multiple sources and communication channels.
• Ability to handle a high volume of work and rapidly adapt to changing environment.
• Ability to make quality and compliance decisions for the site and/or to escal

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.