- Novo Nordisk Inc. (West Lebanon, IN)
- …records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to ... or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Aequor (West Greenwich, RI)
- …Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position ... requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the Following: Provide Quality oversight to ensure that… more
- Aequor (West Greenwich, RI)
- …Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position ... requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the Following: Provide Quality oversight to ensure that… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities performed during ... Position Summary:The Technician I, QA - Finishing provides direct support for all finishing manufacturing activities. This position supports the Quality Systems… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards ... individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the...of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality … more
- Merck & Co. (Rahway, NJ)
- …local policies of work commuting.Essential responsibilitiesManages a team of Quality Assurance professions as direct reports and complies with company requirements ... the CTLs oversight involving samples management/ testing of products with the assurance that the contracted services are in conformance to all applicable policies… more
- Merck & Co. (Rahway, NJ)
- …continue advancing medical innovation and improve lives.SPECIALIST (P-2), -Audit and Assurance ServicesOur Company Corporate Audit and Assurance Services' ... is to provide value-added independent and risk based audit and assurance services.Position Responsibilities:Under the direction of the Client Audit Director ("CAD")… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research QA including activities ... relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence… more
- Aequor (Waltham, MA)
- …years of relevant experience Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) Working knowledge and ability to apply Quality ... forms, WI, and any other document types Assist with internal and external audits. Support of data analysis and metrics for QMR, KPIs, and other reportable forums may… more
- Aequor (West Greenwich, RI)
- …experience in detail during the interview.Responsibilities: Primary focus is the support and oversight of 's Quality Management Systems ensuring key requirements ... Systems comply with cGMP practices and other applicable regulations Provide support for Global Process Owners executing key quality systems processes Ensures… more
- PlanIT Group (Troy, AL)
- …on product quality issues and effective issue resolution. Additional responsibilities include support of product safety and EH&S initiatives. * A self-starter with ... the ability to work in a fast-paced, changing environment with minimal supervision. * Proven experience in performing root cause investigations and implementing effective corrective action. * Knowledge of MS office products (Word, Excel, and PowerPoint). *… more
- PlanIT Group (Stratford, CT)
- …customer representatives and Center Engineers, and technicians to include the Quality Assurance customers requiring support . * Safety Compliance: Follow safety ... of any Job Safety Analysis for never performed or one off non-standard testing. * Support customers in research and process walks of testing in an effort for them to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as applicable) to support the execution of ... team based in Raritan, NJ. Role OverviewThe Process Validation Technician will support the validation department in establishing a robust and sustainable Aseptic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.Collaborate with Quality Assurance , ... various QC Microbiology department projects, supporting laboratory investigations, and support and track all process improvement projects.Key Responsibilities … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in ... for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance ... to cGMP facility to manufacture products.Work with cross-functional departments to support the manufacturing of autologous CAR-T products for clinical and commercial… more
- Merck & Co. (Rahway, NJ)
- …play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance of complex devices, such as auto-injectors and other complex drug… more
- Eisai, Inc (Nutley, NJ)
- …framework and compliance control framework.Oversee global IT compliance training programs. Support regional IT Security teams in implementing global security ... global teams in the execution of Risk and Compliance initiatives and support professional growth.Risk Management: Develop and manage global risk management processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure SOP updates are coordinated across functions and/or initiatives to support timely implementation while minimizing change. Identify, escalate, and plan and ... Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. Provide reviews… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsible to support PV Quality System audits at our company's Animal Health own sites/entities, CROs and system audits. Support to monitor all ... externally with CRO's, laboratories, contactors, and external business partnersPerform and Support PV audits as required.Review and Approve Corrective and Preventive… more
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