- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Eisai, Inc (Raleigh, NC)
- …of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record ... investigation and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality systems.Strong oral and written… more
- Merck & Co. (Rahway, NJ)
- …BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… 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 ... for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the...and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross… 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 ... with all company and/or site policies and proceduresSupport maintenance driven quality events including but not limited to Deviations/Investigations, Out of… more
- ProCaps Labs (Henderson, NV)
- …Partner with the Quality Control team to ensure compliance with GMP , FDA , and industry standards. Investigate and resolve production issues, implementing ... in soap or chocolate manufacturing. Technical & Leadership Skills: Strong knowledge of GMP , FDA regulations, and quality systems related to food or drug… more
- Compunnel (El Segundo, CA)
- …or Engineering discipline, or equivalent experience in manufacturing with a focus on quality . Knowledge of FDA and ISO compliance, including auditing, SOPs, and ... experience in a regulated manufacturing or laboratory environment. Familiarity with GMP , GLP, and other quality compliance frameworks. Experience working… 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 ... Pall is there, helping protect critical operating assets, improve product quality , minimize emissions and waste, and safeguard health. For the exponentially… more
- Alkermes (Waltham, MA)
- …EU and FDA regulatory requirements and align with internal company quality standards ESSENTIALS AREAS OF RESPONSIBILITY: QA support for onsite Phase I/II oral ... Job Description Product Quality Lead POSITION SUMMARY: Provide onsite Quality...These activities may include: QA review and approval of GMP documentation related to onsite GMP activities,… more
- Vetio (Jupiter, FL)
- About the job Quality Supervisor (Supplement & Food Safety) SUMMARY: The Quality Supervisor oversees and ensures compliance with FDA 21 CFR Part 111 ... proper documentation practices and control of SOPs, forms, and logs. Coordinate employee GMP training and maintain training records. Support Quality Control in… more
- Vetio (Jupiter, FL)
- …and wipes at Vetio Animal Health. This role ensures compliance with USP, FDA , and internal quality standards while collaborating with procurement and ... (pharmaceutical or cosmetic) environment. Working knowledge of USP/NF standards and GMP /GLP requirements. Experience with quality systems and ERP/inventory… 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. ... Quality Technician Bradenton, FL Goldflower Cannabis About Us:...a passion for the cannabis industry. Assist in monthly GMP /Sanitation Inspections Daily hygiene and sanitation checks Perform glass… more
- Coregistics (Acworth, GA)
- …Fast Moving Consumer Goods - FMCG.) Deep understanding of food safety regulations, GMP , HACCP, and SQF standards. Familiarity with FDA , USDA, and other ... Quality Manager Position Summary: The Quality ...ensure food safety and regulatory compliance (including SQF, HACCP, GMP , and FSMA) Establish, update, and enforce policies and… more
- New York Blood Center Inc (Rye, NY)
- …and FDA reporting of errors. Independently monitors and assesses quality performance and compliance of operational systems. Manages deviation reporting process, ... meetings with operational staff and managers. Coaches NYBCe staff in GMP and quality principles. Advises staff regarding regulatory and quality issues,… more
- BayOne (Raleigh, NC)
- …Quality Management and Oversight Responsible for the global strategic oversight of R&D Quality GMP activities as related to Medical Devices (non-EBD and EBD) ... skills Ability to effectively multitask and manage multiple projects Experience with FDA , European agency regulations, cGMP regulations, and Quality Management… more
- Revolution Medicines (Redwood City, CA)
- …FDA , EMA, PMDA) in support of BIMO/PAI including conducting mock inspections at GMP establishments. Certified Quality Auditor, CQA (ASQ), ISO lead auditor or ... pathway. The Opportunity: The candidate will be responsible for conducting quality audits, vendor compliance with regulations of GxP vendors providing regulated… more
- Paleovalley (Mesa, AZ)
- …of processing or packaging. GMP Compliance: Follow Good Manufacturing Practices ( GMP ), Standard Operating Procedures (SOPs), and FDA and USDA compliance at ... Regulatory Guidelines: Ensure all processes are in compliance with FDA and USDA requirements and quality standards....adhere to all safety protocols and Good Manufacturing Practices ( GMP ) standards. Position Type/Expected Hours of Work This is… more
- System One Holdings, LLC (Devens, MA)
- …or related technical field (entry-level to 2+ years' experience) Strong understanding of GMP and FDA regulatory requirements High level of safety awareness in ... of Active Pharmaceutical Ingredients (API) and require strong knowledge of GMP practices and hands-on manufacturing experience in a controlled, aseptic environment.… more
