Sr. Quality Specialist

Fagron; Canton (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Fagron US seeks a Quality Assurance Senior Specialist to lead cGMP QA activities across manufacturing, packaging and distribution of compounded products. This role ensures ALCOA-compliant documentation and effective release processes.

The ideal candidate will demonstrate mastery across Level 1–3 QA tasks, batch records, change controls, CAPA and problem-solving within a fast-paced pharmaceutical environment. Excellent communication and attention to detail are essential.

Qualifications

• College Degree and 8–10 years cGMP experience in a pharmaceutical manufacturing company or equivalent.
• 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.

Responsibilities

• Perform Level 1: manufacturing/packaging clearances, label review, label reconciliation, EMS data review, logbook review.
• Perform Level 2: batch record issuance/review, incoming material review, form/logbook issuance, testing data review, event reports and CAPA.
• Perform Level 3: disposition/release of materials and finished product, document control, change controls, moderate risk deviations.
• Support QA projects of low to moderate complexity and assist with batch records and systems for compounding processes.
• Ensure day-to-day compliance with all requirements for compounded products and related systems.
• Assist with problem identification/resolution for QA issues and participate in inspections/audits.
• Contribute to metrics on quality system effectiveness and ensure cGMP documentation meets ALCOA standards.

Skills

Strong communication skills

Detail-oriented

Adaptability

Problem solving

Education

Bachelor's degree or equivalent

Tools

MS Office (Word, Excel)

MasterControl

Quality systems

Job description

About the Job

The Quality Assurance Senior Specialist is an experienced professional level position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.

Key Responsibilities

• Execute and develop 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
• Demonstrated Subject Matter Expertise in at least two QA functions.
• Takes on QA projects of low to moderate complexity as assigned.
• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
• Assist with internal, corporate, 3rd party and federal/state inspections and audits.
• Provide contributing 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.
• Perform other related duties as assigned.

Basic Qualifications

• College Degree and at least eight to 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.

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

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. Fagron US is proud to be an affirmative action and equal opportunity employer.