QA Lead, cGMP | Batch Release & Compliance

Fagron Tech; Canton, Northern (MA, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

401(k) plan with company matching

Medical insurance

Vision insurance

Dental insurance

HSA

Paid time off

Job summary

Fagron US is seeking a Quality Assurance Supervisor to lead QA activities for cGMP manufacturing, documentation, and product disposition or compliance and quality systems. You will oversee direct reports and drive ALCOA-aligned documentation and change controls.

The role requires extensive cGMP experience, strong QA leadership, and the ability to manage multiple tasks during manufacturing and packaging processes. You will collaborate across QA groups and support internal and external inspections.

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 escalate.

Responsibilities

• Coach and facilitate direct reports’ proficiency in 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.

Skills

cGMP expertise

Quality systems

Aseptic technique

MS Office

Education

College Degree

Tools

MS Word

MS Excel

Job description

Fagron US is seeking a Quality Assurance Supervisor to lead QA activities for cGMP manufacturing, documentation, and product disposition or compliance and quality systems. You will oversee direct reports and drive ALCOA-aligned documentation and change controls.

The role requires extensive cGMP experience, strong QA leadership, and the ability to manage multiple tasks during manufacturing and packaging processes. You will collaborate across QA groups and support internal and external inspections.