- Aequor (Swiftwater, MN)
- Overview of the Position The Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues on ... PA USA. This is a hybrid position. Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking Environment, Health & Safety (EHS) Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewThe Environmental Health and Safety (EHS) Sr. Specialist role is an exempt level position with responsibilities for supporting the Environmental Health and… more
- Merck & Co. (Durham, NC)
- …of raw materials, intermediates and finished products.The Quality Operations Laboratory Associate Specialist works with a team of analysts in commercial and pipeline ... activities at the Durham site.--The Quality Operations Laboratory Associate Specialist will be responsible for testing in laboratories using principles of our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, New ... Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations...ERP and EBR systems during processing hours to ensure GMP standards of ALCOA+ system transactions within operations activity… more
- Merck & Co. (Durham, NC)
- …Responsible for the quality aspects of good manufacturing practices ( GMP ) computerized systems and the supporting infrastructure used in site ... compliance related issues. Contribute to the development and/or maintenance of training programs in the principles of computerized systems validation, computer… more
- Catalent Pharma Solutions (Chelsea, MA)
- ** GMP Training Specialist - QA** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... DPI in North America. Catalent Pharma Solutions is hiring a Quality Systems Specialist ( Training ) who is responsible for administrative management and oversight… more
- Regeneron Pharmaceuticals (Troy, NY)
- …quality and ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist , a typical day might include the ... ensuring compliance with DG policies; crafting and delivering relevant training ; and monitoring DG practices. The role is pivotal...& Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG… more
- ThermoFisher Scientific (Middleton, WI)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degrees, Office, Some degree of PPE ... hazardous/toxic materials **Job Description** Scientist - Cell and Gene Therapy Specialist II, Clinical Lab Scientist Middleton, Wisconsin, United States of America… more
- Catalent Pharma Solutions (Baltimore, MD)
- ** Specialist , QA - Raw Materials** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in ... AAV and other viral vector-based therapies and vaccines. The Specialist , QA - Raw Materials is responsible for ensuring...needed to assure patient safety. Providing QA support for GMP Raw Materials that support the production of … more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The ** Training & Development Specialist ** is responsible for the successful implementation of the ... site Manufacturing Training Program. The ...for new hires to introduce to aseptic processing and GMP space, and process training . + Communicates… more
- Integra LifeSciences (Plainsboro, NJ)
- …possible and making headway to help improve outcomes. **SUMMARY DESCRIPTION** The Senior Training Specialist , QA will create and conduct training programs ... of employees in a medical device-regulated environment. The Senior Training Specialist will assess training ...with subject matter experts, that adhere to GDP and GMP standards. + Identifying training needs by… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex validation ... requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for validation activities… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Specialist II, MTO** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The ... products including AAV and other viral vector-based therapies and vaccines._ The ** Specialist II, MTO** will provide support to Manufacturing Associates to meet… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Specialist , QA OTF** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the ... products including AAV and other viral vector-based therapies and vaccines. The Specialist , QA is responsible for providing Quality Assurance support for GMP… more
- Cardinal Health (Indianapolis, IN)
- …Quality, GMP compliance and EHS/Radiation Safety practices. + Develop and lead GMP /GDP training of all employees. Follows/ mentors GDP/ GMP requirements. ... effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business… more
- Abbott (Abbott Park, IL)
- …Safety; Process Improvements; new process implementation; Cost Containment and Control; GMP ; Inventory Control; Compliance; Training and Skills Enhancement of ... diversity, working mothers, female executives, and scientists. **The Opportunity** The ** Specialist Manufacturing Tech** works out of our **Abbott Park (Lake Bluff),… more
- Astellas Pharma (Westborough, MA)
- …are reviewed / approved prior to issuance. + Will develop and deliver GMP and/or Manufacturing-related training to Manufacturing floor staff and facilitate ... **Sr Manufacturing Specialist , Production Planning** Do you want to be...updates or improvements to on-the-job training platforms while ensuring training curriculum is… more
- Catalent Pharma Solutions (Harmans, MD)
- …seek advice on matters outside the specialist 's knowledge or authority. + Provide training on GMP compliance. **The candidate:** + BS degree in a technical ... The **Facility Compliance Specialist ** will report to the Manager of Facility...provide support for facility quality. Provide regulatory guidance and GMP training to facilities and engineering team… more
- Nestle (Chicago, IL)
- …in quality is a plus - Prefer individual with PCQI/SQF or other professional GMP /Sanitation training . - Prefer individual completed Pest control training (ie ... Factory Food Safety/Sanitation (Hygienist) provides direction / leadership for factory GMP , sanitation, Pest Control and hygienic design programs. This position… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About the Role** The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) ... Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans… more
