- Merck (Durham, NC)
- …Operations Consulting, Operations Management, Pharmaceutical Process Development, Production Planning, Quality Management, Regulatory Compliance {+ 4 more} ... work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn...or related field + Bioworks Certificate (working in an FDA or similar regulated industry) + Applicable mechanical and… more
- Insight Global (Pleasant Prairie, WI)
- …and other controlled documents. ○ Ensure documents meet regulatory standards ( FDA , ISO 13485) and internal quality requirements. * Compliance & Governance ... Procedures (SOP), and Standard Operating Controls (SOC) to ensure compliance with regulatory requirements and internal quality standards for a medical device… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory , and Quality to ensure compliant, efficient, and scalable ... high- quality statistical programming solutions for clinical trials and regulatory submissions. + Set clear goals, conduct performance assessments, and foster… more
- Pfizer (Groton, CT)
- …understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-clinical, Pharmacology, Quality Assurance ... SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs… more
- Catalent Pharma Solutions (Kansas City, MO)
- …three years of relevant experience + Must demonstrate knowledge of CSV, Validation, Quality , IT and Regulatory Compliance. Familiarity with cGMPs, ISPE GAMP5, ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...executed, and documented per KCM SOPs, Corporate Policies and Regulatory guidelines + Represent KCM BioAnalytics as the CSV… more
- ThermoFisher Scientific (Greenville, NC)
- …Lead QA Technician, you will play a critical role in ensuring product quality and regulatory compliance within pharmaceutical manufacturing operations. As part ... batch record review to ensure accuracy and compliance with regulatory and internal requirements + Lead and support deviation...Skills, and Abilities** + Advanced knowledge of GMP regulations, FDA guidance, and pharmaceutical quality systems +… more
- Patterson Companies, Inc. (St. Paul, MN)
- …brand products. This role is critical in ensuring the procurement of high- quality products while maintaining cost-efficiency and meeting regulatory requirements. ... price, delivery, and service performance. + Collaborate with internal teams (marketing, quality assurance, regulatory affairs, supply chain and finance) to… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …roles and responsibilities and relationship between Olympus and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA , ISO 13485, ... industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and… more
- ManpowerGroup (Mendota Heights, MN)
- …for sourcing. This role is critical in ensuring the procurement of high- quality products while maintaining cost-efficiency and meeting regulatory requirements. ... price, delivery, and service performance. + Collaborate with internal teams (marketing, quality assurance, regulatory affairs, supply chain and finance) to… more
- Globus Medical, Inc. (Audubon, PA)
- …records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development strongly preferred + Comprehensive knowledge of GMP, FDA , CBER, and CDRH regulatory requirements +… more