- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Quality Management System (QMS) establishment processes in collaboration with GMP Quality System function. Supports the development and implementation of ... Ensure effective collaboration with DS affiliates to promote a culture of quality that drives performance and teamwork.Responsibilities: GMP Audit: Support the… more
- Merck & Co. (Durham, NC)
- …Shift before transitioning to Third (3 rd ) Shift Preferred Experience and Skills: GMP quality experience with media, biological drug substance and drug product. ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager will… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Associate Director/ GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the ... and Skills: Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment GMP Compliance… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- … Operations in maintaining an effective Quality Assurance (QA) program, and GMP Quality Management System which consistently delivers high quality ... complaints. This person and their team assist in maintaining the companys GMP Quality Management System program. ESSENTIAL DUTIES: Operates under the guidance of… more
- Butterball (Calypso, NC)
- …with limited Supervision Knowledge of Workplace Safety Rules Performs checks of Product Quality against specifications Assures GMP , HACCP, and SOP's are in ... compliance Investigates issues related to Quality and Food Safety Collects Microbiological and Product samples...of the Process Assists with audits of the process, GMP 's and Food Safety as well as Customer Audits… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and ... direction for transitioning from clinical to commercial phase GMP operations.Partners with other internal and external Quality Heads to ensure harmonization and… more
- Cipla (Fall River, MA)
- …is required for this position. Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment. ... responsible for managing controlled documents to ensure compliance with GMP , GDP, and regulatory standards such as FDA 21...Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and… more
- Cipla (Fall River, MA)
- …accredited college/university is preferred. Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation and work ... (May vary based on business needs) Reports To : Quality Assurance Manager Salary Range : $21 - $26...Manufacturing Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing… more
- Merck & Co. (Rahway, NJ)
- …is preferable. GMP : Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report ... Computer Literacy, Data Analysis, FDA Regulations, Good Manufacturing Practices ( GMP ), Laboratory Techniques, Manufacturing Quality Control, Master Batch… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... relocations Lab Based Job Bachelor's degree. Nice to have: documentation practices, GMP , previous lab experience. Hiring Manager Intake Notes What type of… more
- Formation Bio (New York, NY)
- …and manage drug product vendors, for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards. ... Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support… more
- Merck & Co. (Rahway, NJ)
- …is preferable. GMP : Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.Expertise in GMP compliance ... and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA/EU guidance related to… more
- Aequor (Thousand Oaks, CA)
- …are supporting Rotate every 6 months The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at 's USTO site. ... events. Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment (preferably within biotech or ) with strong critical thinking skills… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, ... Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both… more
- Merck & Co. (Rahway, NJ)
- …both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, ... new technologies, trialing new automation strategies, and implementing them in the GMP areasSupport capital projects, work to design, install, and qualify new… more
- Formation Bio (New York, NY)
- …of CSV is preferred. Strong working knowledge of global regulatory requirements, including GMP , GCP, and ICH guidelines. Expertise in Quality Management Systems ... the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance. In this pivotal role, you will have the opportunity to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Document Control Specialist role ... support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review and approve SOPs, and… more
- Repligen (Waltham, MA)
- …an experienced and driven IT Business Partner to represent our Manufacturing, Quality , Supply Chain, Product Development, and R&D organizations. As a Director of ... ResponsibilitiesServe as the primary IT liaison for the Manufacturing, Quality , Supply Chain, Product Development, and R&D organizations.Partner with business… more
- Merck & Co. (Rahway, NJ)
- …statistical data analysis.-Primary ResponsibilitiesSupport execution of Good Manufacturing Practices ( GMP ) activities such as release and stability testing to ... ALCOA principals.Troubleshoot and investigate any challenges associated with the GMP testing through active collaboration with cross-functional project teams and/or… more
