- Cambrex High Point (Agawam, MA)
- …provide a variety of support for laboratory functions in accordance with SOP's & GMP practices. This role is responsible for the cleanliness of the laboratory and to ... Other duties as assigned by management Qualifications/Skills + Basic understanding of GMP requirements + Good understanding of company SOP's & requirements +… more
- Catalent Pharma Solutions (Chelsea, MA)
- …purposes. This individual provides strategic and operational direction ensuring that GMP testing is conducted in line with the appropriate expectations, guidelines ... flows, laboratory equipment, and staff training + Responsible for GMP compliance as related to the laboratories, equipment, and...regulatory audits preferred, but ability to apply applicable regulations ( FDA , EU, Japan, USP, ICH, etc.) in a phase… more
- Bristol Myers Squibb (Devens, MA)
- …with cross functional teams. + Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have ... knowledge of GMP Manufacturing operations and processes. + Directs quality initiatives...2+ year of QA shop floor experience. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is… more
- Integra LifeSciences (Braintree, MA)
- …and analyze process data. + Assist in preparing for, and participating in FDA audits, internal audits, and other regulatory agencies audits. + Demonstrate excellent ... in microbiology, Biology or related field preferred. + 5+ years GMP /GLP laboratory experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... + Ensure that all projects are in compliance with GMP , QSR, ISO or other applicable requirements. + Identify...with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of… more
- Abbott (Westford, MA)
- …performing team. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... experience with companies engaged in the manufacture of high quality, FDA regulated products. + Proven leadership skills, results oriented, highly collaborative,… more
- Integra LifeSciences (Braintree, MA)
- …Process Validation, or other studies as deemed necessary. + Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal ... projects. + Maintain all projects are in compliance with GMP , QSR, ISO or other applicable requirements. + Identify...with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of TrackWise preferred. + Knowledge of… more
- Charles River Laboratories (Boston, MA)
- …by delivering operational and cost efficiencies through the strategic insourcing of GMP , GLP and non-GLP research services from discovery through safety assessment. ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Bristol Myers Squibb (Devens, MA)
- …in a manner consistent with the safety policies, quality systems, and GMP requirements. + Completing training assignments to ensure the necessary technical skills ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- J&J Family of Companies (Danvers, MA)
- …in a supply chain related role + Experience with SAP and EWM + Experience in FDA regulated industry and familiarity with CFR 21 Part 11, GMP , SAS, and Sarbanes ... Oxley is a plus + Excellent Presentation, Communication and Inter-Personal skills + On-site position in Danvers (MA) Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race,… more