Manufacturing QA (Canton, MA)
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.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.
- 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.
- Support problem identification and resolution efforts for quality related issues associated with the compounding operations.
- Ensure appropriate investigation and closure of incidents, change controls, and complaint investigations; direct 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.
- Represent QA 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.
- Performs other related duties as assigned.
- Bachelors degree in a scientific discipline and at least three years of relevant Quality Assurance experience in a pharmaceutical manufacturing company.
- 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
Sthree US is acting as an Employment Business in relation to this vacancy.