- Exela Pharma Sciences, LLC (Lenoir, NC)
- …applicable areas Provide QA oversight to pharmaceutical Operations and perform acceptance quality limit (AQL) inspection Perform Quality Assurance compliance ... direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and information needed to ensure oversight of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes so these data may be ... immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and...the Global RD/PV QA team. May be assigned other Inspection Management Team (IMT) roles in support of … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of six (6) years of experience in Quality Assurance/ Quality Systems or ComplianceExperience conducting internal audits (self- inspection ), including writing ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in… more
- Merck & Co. (Durham, NC)
- …expert for internal and regulatory inspections. Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness. T ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. Provide ... coordinate SOP Training and effectiveness beyond Read and Apply training in LMS. Inspection Readiness Provide support for audits, inspections and inspection … more
- Merck & Co. (Durham, NC)
- …areas (sterile supply, weigh/dispense, media, stabilizer/prep, Drug substance, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean room ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups. This position will be for second… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Aequor (South San Francisco, CA)
- …department is to optimize the support of clinical systems to provide high- quality clinical trial data insights and to offer data science-related consultation to ... of driving data-driven decision-making throughout the study lifecycle. The Risk Based Quality Management (RBQM) Data Analyst sits in the Data Intelligence team and… more
- CR Machine Co Inc (Billerica, MA)
- …production of CNC machines by means of loading/unloading CNC machines, part inspection and troubleshooting. Read and interpret blueprints & drawings. Knowledge of ... basic measuring tools (ie; micrometers, calipers, indicators & gauges). Maintain quality and safety standards. Qualifications: High school diploma or equivalent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for ... with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers. Develop… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management & mitigation...on site. May position oneself within confined spaces for inspection if required of the role. Ability to work… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Primary Responsibilities: The… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation ... Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) Performs all job duties and responsibilities in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that ... and trends in the areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and… more
- Merck & Co. (Rahway, NJ)
- …in accordance with identified target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure appropriate submission, ... a site program such as Manufacturing, Research, Tech Ops function, Quality or EHS Plant.Leadership in pharmaceutical or chemical industry.Robust skills interpreting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics. This individual will ... investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. This individual will… more
- Genmab (Plainsboro, NJ)
- …and change controls in connection to Clinical Drug Supply OperationDrive Inspection and Audit preparation and executionResponsible to be compliant with Genmab's ... quality systemRequirementsMinimum a Bachelors with 3-5 years experience. Master's degree with +2 years experiences, or PhD's degree with +1 year of experience, or… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In addition, this ... projects within the area of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational trial… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... perform close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including… more
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