Manufacturing Quality Assurance Specialist III
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The Opportunity
Description
We're looking for a Manufacturing Quality Assurance Specialist III, working in Pharmaceuticals and Medical Products industry in 20 Dan Rd #1, Canton, Massachusetts, 02021, United States.- Support development and 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 product compounded and the systems supporting compounding.
- Lead 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. Advise and assist in the disposition of incoming material and final product. Perform other related duties as assigned.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- Bachelor’s degree in a scientific discipline with 3 to 5 years of relevant
- Quality Assurance experience in a pharmaceutical manufacturing company.
- Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan).
- 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.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
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