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Applied knowledge and good understanding of analytical and/ or microbiology testing techniques, as well as other technical areas related to pharmaceutical manufacturing, packaging, distribution, statistical methods, and quality control and assurance practices.
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Responsibilities: Bachelor's degree in relevant scientific, engineering, or computer-based area, with minimum of years' experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience Quality management system experience including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management database Knowledge of cGMP regulatory requirements, computerized analytical systems.
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Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Qualifications Required •Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
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Minimum of - 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at BMS or other company. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Bristol-Myers Squibb is seeking a quality control professional to join our QC Incoming Materials team, performing QC testing in on raw materials in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with client policies, standards, procedures, and Global cGMP. Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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A minimum of 2-4 years of experience in a Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab. Performs routine testing and data review of Incoming Materials in a cGMP compliant environment.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The QC Analyst is responsible for supporting Quality Control analytical testing of Incoming Raw Materials. Title: Quality Control Technician. Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Minimum 4 years relevant work experience, with experience in a Quality Assurance role. Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The candidate will work 2 - 10:30 PM hour shift M>Fri as detailed in JD. Candidate must have Quality Assurance experience with strong independent judgment. Routinely recognizes and resolves Quality issues; Informs management of proposed solutions.
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The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF. Please be sure candidates understand and can work this schedule for this time period, and then be available to move to the 2nd shift work schedule.
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Job Description: Field QA Specialist Devens, MA This role is 100% Onsite Work Schedule: Mon - Fri, 2PM - 10:30 PM EST Traning Shift : This is 8 - 10 weeks on 1st shift which is 7AM - 3:30PM Mon - Fri JOB SUMMARY Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Single Use Facility (SUF) in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Review all data in accordance with applicable procedures and cGMP requirements. Document training per procedural and cGMP requirements. Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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On-Board Scientific is hiring a Quality Control Technician in Devens, MA! Job title: Quality Control Technician. Performs routine testing and data review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant environment.
Full-timeExpandApply NowActive JobUpdated 18 days ago
cgmp quality control jobs in Devens, MA
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