QA Lead (4 openings) Job in Devens 01434, Massachusetts US
Quality Assurance LeadUp to a 24 month contract w/ opportunity to pursue direct hire roles while there as a contractor.New pharmaceutical manufacturer getting ready for productionLocation: Devens, MA2nd ShiftSummary: Maintains shop floor quality presence; releases raw materials, in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews.
Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines.
May assist in preparing for a hosting of regulatory and customer audits1 Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs2 Samples, inspects and releases consumable and raw materials per specifications3 Monitors various stages of processing along with the appropriate paperwork in compliance with specifications4 Drafts and reviews specifications and SOPs.
Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing5 Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data6 May provide guidance to less experienced staff7 Provides QC support including lab inspections, method qualification, method technology transfer, LIMS and Smart Lab support, etc.Requirements: - B.
S., in Science, Engineering, Biochemistry or related discipline, or its equivalent is preferred.
- 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of SAP, LIMS, Trackwise, Smartlab are a plusNo Relocation Assistance or Interview Cost ReimbursementsRequired Skills: BATCH RECORDSJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation.
Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities.
At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more.
Don't put your career in the hands of just anyone, put it in the hands of a specialist.
Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
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