Responsible for quality assurance activities/decision making associated with cGMP manufacturing, investigations, change control, complaint investigations and documentation. Ensures that proper controls are instituted and maintained during the manufacturing, processing, packaging and warehousing of compounded product.
- Support implementation of Master 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.
- Support appropriate investigation and closure of incidents, change controls, and complaint investigations; monitors implementation of appropriate solutions.
- Review and approve manufacturing batch records, QC testing, SOPs and other batch related documentation.
- Assist with internal, corporate, 3rd party and federal/state inspections and audits.
- Provide reports on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
- Participate in QA meetings for Product manufacturing and Media Fill execution.
- Ensure cGMP documentation associated with work activities is complete.
- Maintain assigned standard operating procedures.
- Assist in the disposition of incoming material and final product.
- Perform other related duties as assigned.
- Bachelor’s degree in a scientific discipline or three (3) to five (5) years equivalent education/Quality Assurance experience in a pharmaceutical manufacturing company required.
- Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan) and Trackwise preferred.
- Excellent problem-solving skills.
- Ability to work in a fast-paced environment.
- Ability to handle a high volume of work and rapidly adapt to changing environment.
- Preferred skills include root cause analysis and six sigma methodology training.
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.