Senior Quality Control Associate
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The Opportunity
Description
We're looking for a Senior Quality Control Associate, working in Pharmaceuticals and Medical Products industry in 300 Third Street, Cambridge, Massachusetts, 02142, United States.- Working collaboratively with the raw material vendors, internal quality control, process and analytical sciences, manufacturing, and quality assurance departments to ensure that the raw material specification packages meet the company and regulatory expectations
- Ensuring change control, raw material request form, vendor assessment, risk assessment, classification, specification document, and justification of specifications, materials receipt, sampling, and release requirements are in place in a timely manner.
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 degree or 10+ years of GMP QC laboratory or biotech/pharmaceutical industry experience.
- Prior experience in technical oversight of QC raw material sampling, testing, and specification is required.
- Expertise in the raw materials program, including a clear understanding of various regulatory requirements.
- Direct involvement in material specification setting and justification is preferred.
- Understanding of USP, Ph EUR, and JP compendia requirements.
- Prior experience in GMP and Regulatory settings a plus.
- Excellent interpersonal and communication (verbal and writing) skills.
- Good understanding of GMP and regulatory guidelines.
- Good knowledge of statistical methods and computer skills.
- Would be beneficial but not required: knowledge of Oligonucleotides-related raw materials.
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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