PSG Global Solutions Quality Control Contractor in Marlborough, Massachusetts
We're looking for a Quality Control Contractor , working in the Pharmaceuticals & Medical Products industry in Marlborough, Massachusetts .
Interacts with internal multidisciplinary teams to ensure successful delivery schedules of analytical test report/certificates.
Assists with QC checks and preparation of regulatory filings (INDs and NDAs).
Manages projects associated with drug substance and products.
Manages drug substance and drug product (commercial and CTMs) analytical testing at contract laboratories, as well as references standard program at contract laboratory.
Manages stability programs including maintenance of master stability protocols and evaluation of stability requirements, planning and coordinating stability studies, creating and maintaining stability study plans, performing data analysis, authoring stability reports.
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
2 years of experience in an FDA-regulated biotechnology
Knowledge of analytical testing concepts and principles such as Liquid Chromatography
Knowledge of current Good Manufacturing Practices (cGMPs) including laboratory controls and good documentation practices
Working knowledge of a variety of guidance documents from the ICH, FDA, and other global regulatory authorities
Ability to work independently and as a member of cross-functional teams comprised of internal and/or external contacts
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
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? Apply here .
Not exactly? Join Our Talent Community (https://jobs.psgglobalsolutions.com/register) , and we'll let you know of additional opportunities.
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PSG Global Solutions
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