- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will ... direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction,...proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review… more
- Merck & Co. (Rahway, NJ)
- …Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API (including new modalities such ... ADCs) are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and… more
- Insmed Incorporated (San Diego, CA)
- …with colleagues in other departments to increase the overall effectiveness of the Quality departmentAssist in other quality assurance related activities as ... similar function.Full understanding of GMP and Gene Therapy manufacturing.Familiarity with Quality Assurance aspects in manufacturing processes of new… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with ... investigations, deviation management, and Corrective/Preventative Actions (CAPAs)Previous background in quality control, quality assurance , auditing, or… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance , the Associate Director Quality Engineering & Quality ... (ISO 14971) and other worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on Quality Assurance record review and approval by Manager, Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager ... ancillary support records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and… more
- Merck & Co. (Durham, NC)
- …pharmaceutical operations, technical operations, validation and/or process Quality Assurance .Required Experience and Skills:Strong Batch Record Review and ... and process qualification.Provides Quality input, direction, and approval of Quality Notifications (QNs) and ChangeRequests (CRs). Author, review , and… more
- Novo Nordisk Inc. (Durham, NC)
- …(BPRs) & relevant quality processes are compliant with regulations. Performs quality review & approval of Change Requests (CR's) & other documentation ... in the pharmaceutical or medical device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS)… more
- Merck & Co. (Durham, NC)
- …experienceAseptic Gowning knowledge and techniquePrevious shop floor quality , quality control or quality assurance experienceExperience with ... in a fast-paced environment, be hands-on, prioritize, analyze and review potential risks and gaps is a must. Assessment...to support business needs. Primary Responsibilities: Member of the Quality Sterility Assurance team, providing support to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in continuous process improvement activities within QA, as necessary.Participate as a Quality Reviewer for Health Authority inspections in the US, in ... closed in a timely manner.Regulatory Inspections: Participate as a Quality Reviewer for Health Authority inspections in...data and information needed to ensure oversight of ongoing review of risks by evaluating Quality Events… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …monitoring and oversee the conformance to the QMS through internal audits and management review . In addition, the Quality Director will represent the company as ... and facilitating corrective and preventive actions including:Provide management oversight for quality control, batch records, and material review board.Provide… more
- Merck & Co. (Durham, NC)
- Job DescriptionQuality Engineering (QE), part of Durham's Quality Assurance (QA) organization, in Building 160 (B160) is seeking a Quality Specialist (P2) ... directly with Quality Operations (QO), Shop Floor Quality Assurance (SFQA), Sterility Assurance ...documentation for sustained compliance with QMS guidelines. Support technical quality review of critical utilities and facility… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... and updates essential Laboratory documents as per current regulatory guidelines. Review and Compilation of Analytical Data required for Regulatory filings.Serves… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed a new manufacturing facility to significantly expand its ... inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion....and/or GLIMS. Experience in deviation management with focus on quality review and approval. Experience in Aseptic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …members, IT and Patient Safety on automation and technical enhancements that may make quality review more efficient or scalable Analyze call center data to ... Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management, operations and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or ComplianceExperience conducting internal ... team, ad hoc, for activities such as annual product review , site risk register, or internal quality ...product review , site risk register, or internal quality agreements.Develops and delivers training for specific quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operations and perform acceptance quality limit (AQL) inspection Perform Quality Assurance compliance review of manufacturing, maintenance, and ... provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring… more
