What are the responsibilities and job description for the Quality Assurance Senior Specialist (Canton, MA) position at Fagron?
Who We Are
Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.
If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love! Together we create the future of personalizing medicine.
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. Demonstrated Subject Matter Expertise in at least two QA functions.
Pay: $100,000 USD Annually
Key Responsibilities
Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.
If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love! Together we create the future of personalizing medicine.
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. Demonstrated Subject Matter Expertise in at least two QA functions.
Pay: $100,000 USD Annually
Key Responsibilities
- 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.
- 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.
- Maintain the Fagron Family Values of Quality, Customer is #1, Transparency, Entrepreneurship, Creativity, and Speed of Execution while performing job responsibilities.
- Follow Fagron Family Rules
- Contribute to QA Team success by participating in problem solving discussions and seeking to understand the “Why?”
- Strive for continual learning and improvement
- Develop Subject Matter Expertise (SME) in two or more QA functional areas (e.g., Doc Control, Release, QC Support, and etc.)
- Lead by example for more junior QA staff.
Salary : $100,000