- Aequor (Athens, GA)
- …laboratory environment. Preferably experience with Documentum, MS Teams, MS Sharepoint. 21CFR Part 11, GLP ( FDA and EPA), GMP ( FDA and EU), VICH Internal BI ... policies on Records Management, Training Management, Information Protection. The individual must be very detail oriented and able to follow precise instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in ... plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and… more
- Merck & Co. (Durham, NC)
- …candidate will participate in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs ... water.Good technical writing skills and high attention to detail.Previous GMP -laboratory experienceWork independently and within a team environmentPreferred:Experience with… more
- Merck & Co. (Rahway, NJ)
- …under pressure.Demonstrates strong attention to detail.Process-oriented with familiarity of GMP requirements and working in a highly regulated industry.Experience ... Documentation requirements and processes pertaining to system management for GxP/ GMP applications.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- Merck & Co. (Rahway, NJ)
- …is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in ... options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience… more
- Merck & Co. (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... experience integrating PAT efforts)Experience with on-the-floor Good Manufacturing Practice ( GMP ) manufacturing support, familiarity with manufacturing batch record reviews… more
- Eisai, Inc (Raleigh, NC)
- …a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing, auditing, batch release ... and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality systems.Strong oral and written communication… more
- Merck & Co. (Durham, NC)
- …tools Experience with responding to regulatory questions with multiple agencies (eg FDA , EMA) Experience with face to face presentation of technically complex ... Collaborative Communications, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices ( GMP ), Lean Manufacturing, Manufacturing Support, Personal Initiative, Process Innovation,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ensure operational efficiencies and successful production of API onsite. Prior experience in a GMP environment or life science industry is a plus for this role. This ... and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross...systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …devices, circuits, and switchgear used in cGMP and non GMP systemsInvestigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation ... federal regulations including and equivalent to Federal Drug Administration ( FDA ), Environmental Protection Agency (EPA), Occupational Safety and Health… more
- Pall (Miami, FL)
- …understanding of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage.Good understanding of ... applicable regulatory requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)The salary range for this role is 155,000 - 180,000. This is the range that we… more
- Group Management Services (Bradenton, FL)
- …industry preferred but not required. Strong understanding of regulatory requirements (eg, FDA , GMP , or state cannabis regulations). Preferred but not required. ... practices, and a passion for the cannabis industry. Assist in monthly GMP /Sanitation Inspections Daily hygiene and sanitation checks Perform glass and brittle checks… more
- Crown Bakeries (Nashville, TN)
- …products, Quality Systems: Support manufacturing facility quality systems (FSMA, GFSI, BRC/SQF, FDA , USDA, GMP ) Participates in all 3rd part audits (including ... complaint response, sales sample requests, and customer product evaluations. Ensures any GMP , food hygiene and safety standards are within compliance. Report any… more
- Equiliem (Tipp City, OH)
- …and receiving operations This position is accountable for complying with applicable FDA ( GMP ), USDA, OSHA and Client regulations, policies, procedures or ... safety and adhering to the safety guidelines Must communicate safety and GMP concerns to Plant Material Control/Columbus Distribution Center leadership & follow up… more
- Fortive (Irvine, CA)
- …and increase productivity. Ensure all designs and projects are compliant with GMP , FDA , ISO 13485, and applicable regulatory requirements. Required ... components, and equipment used in our sterilization products and GMP -regulated manufacturing environment. This individual will support new product introduction,… more
- Steris Corporation (Libertyville, IL)
- …moderately complex Customer products according to established specifications and procedures within FDA , ISO and GMP guidelines using work instructions and ... to a team effort by performing in accordance with all STERIS policies, GMP , Lean principles and other directives; supports the directives and decisions of… more
- Boston, MA Area Jobs (Marlborough, MA)
- …and validation protocols; perform testing to ensure compliance with regulatory standards ( FDA , GMP , ISO); conduct data analysis, troubleshoot validation issues, ... control processes, and ensure compliance with Good Manufacturing Practices ( GMP ) and FDA regulations. Work location is Marlborough, MA, but requires travel… more
- Actalent (Hilliard, OH)
- …within, and provide valuable experience working in a heavily regulated environment (following GMP and FDA regulations). An ideal candidate will have reliable ... Diploma or GED. Must have manufacturing or production experience. Experience in GMP , FDA , or following strict SOP environments preferred, but not required Pay… more
- GRIFOLS, SA (Los Angeles, CA)
- …discipline is preferred. Minimum of 2 years of related experience in a pharmaceutical, GMP , or FDA regulated environment is required. Equivalency: In lieu of an ... minimum of 4 years of related experience in a pharmaceutical, GMP , or FDA regulated environment. Requires an in depth understanding of pharmaceutical… more
