Quality Assurance Senior Supervisor (Canton, MA)

Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient.

About The Job

The Quality Assurance Senior 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.

Pay: $135,000 USD Annually

Key Responsibilities

• 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.
  
  

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 escalate any questions.
  
  

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.