Quality Assurance Supervisor

Fagron; Canton (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with company match

Medical, vision, dental insurance

Health Savings Account (HSA)

Paid time off

Job summary

Fagron is seeking a Quality Assurance Supervisor to lead the QA team in supporting cGMP manufacturing, documentation, and product disposition. The role ensures proper controls are maintained during compounding, packaging and warehousing, with oversight of site quality systems to meet compliance.

The supervisor will coach QA staff, manage batch records, change controls and investigations, and drive continuous improvement in quality metrics.

Qualifications

• Bachelor's degree and 10+ years of cGMP pharmaceutical experience
• Experience with quality systems, CAPA, Change Control and document review
• Proficient in MS Office programs including Word and Excel

Responsibilities

• Lead a QA team with 3–7 direct reports (QA Generalist/Specialist/Officer)
• Coach and develop staff across Level 1–3 QA tasks
• Approve Batch Records; review testing data and events
• Review and approve Change Controls and CAPA investigations
• Ensure cGMP documentation meets ALCOA standards
• Lead or assist with internal and external inspections and audits
• Track KPIs and manage performance of direct reports
• Provide QA guidance for manufacturing functions and compliance
• Support manufacturing quality systems for compounding processes

Skills

Quality systems

Aseptic technique

cGMP document review

Quality investigations

CAPA

Change Control

Decision making

Education

Bachelor's degree

Tools

MS Office

MasterControl

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.