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Experience in GMP Pharmaceutical/Biologics and performing comprehensive data review. Experience with HPLC, Gel Electrophoresis, UV-Vis Spectroscopy, or wet Chemistry, preferred, not required. You are a valued influencer and mentor who has contributed to QC assay review of a Biologics or Pharmaceutical organization.
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Comply with all health, sanitation, GMP, and USDA regulations as described in the Employee Handbook and other policy and procedure documents. Previous experience in a warehouse, shipping, and receiving role, preferably in a distribution or manufacturing environment.
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Support and enforce company goals and objectives, policies, and procedures, GMP, GDP, FDA QSR, and ISO regulations. Abiomed is recruiting for an NPI Operations Manager, located in Danvers, MA.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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5+ years of Quality Assurance experience in a QSR (GMP), disposable medical device environment. Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Six Sigma Green Belt (Black Belt preferred) certification. LEAN Manufacturing certification and proven track record of implementation. Partner with research and development to ensure DFM during early stage of product development.
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Multiple subassemblies for various OUs including SH, CRM, CRDN, PVH, PV, NM, etc. Assist with writing and exectuing process validation procedures in accordance with QSR, FDA and international guidelines.
$65 an hourExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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O Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines. Voluntary Dental, Vision, Life, Supplemental Income. In this exciting role as a Senior Quality Engineer you will have responsibility for providing comprehensive support in areas of pre-production component development and production-ready component and finished device manufacturing.
$60 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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As the Microbiologist, you will be responsible for supporting the development of microbial retention filter testing protocols in compliance with ASTM and GMP guidelines. General knowledge of GMP guidelines, regulatory requirements and quality control processes related to microbial control and filtration is a plus.
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May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma.
Full-timeExpandUpdated 14 days ago
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