- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training ... give a real-world experience into the regulated environment. We are currently seeking a GMP Quality Assurance Intern for the year starting in June 2024. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Global Quality Systems groups to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and its GMP vendors.Supports ... at all levels.Create and maintain project management methodologies. Support the global GMP quality annual objectives, strategic initiatives to deliver against… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- BioAgilytix (Boston, MA)
- …to the patients who need them.We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our ... roleNot less than six (6) years' experience in GLP/GCLP quality assurance (QA)Not less than eight (8)...Laboratory Practice (GCLP) principles, and/or FDA Good Manufacturing Practice ( GMP ) and industry standards as they apply to the… more
- Catalent (Philadelphia, PA)
- …in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management of materials at Catalent-Philadelphia. Assist in… more
- Aequor (Thousand Oaks, CA)
- …they are supporting Can rotate every 6 months This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight ... The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve… more
- Merck & Co. (Durham, NC)
- …and patients on time, every time, across the globe.-The main functions of the Specialist, Quality Assurance is to assist in the review of batch records, media ... operational excellence initiatives as well as working to implement quality system initiatives and continuous improvements.-Core responsibilities:Supports the deviation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …deviations, CAPAs, and/or managing change controls in the Veeva Digital system. The Quality Systems specialist will support GMP activities to ensure compliance ... approving CAPAs in Veeva.Write/update SOPs and other documentation pertaining to Quality SystemsPotential participation in health authority, 3rd party, and internal… more
- Aequor (Thousand Oaks, CA)
- … Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance , Quality ... -4:30 pm (flex) -Monday - Friday **Candidates must have GMP and pharmaceutical experience** What you will do Let's...vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as ... for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality , integrity… more
- Catalent (Manassas, VA)
- POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection and verification of the products and production processes along all the ... cGMP and execute corrective actions when needed. Assist the Quality Assurance team with special projects as...of experience in regulated environment is required. Knowledge of GMP and Quality systems; Ability to read… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , MSAT or ... seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Aequor (Bothell, WA)
- …reviews specifications and SOPs. 5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. 6. May ... of college who have a biology or similar degree who are looking for GMP experience.* Maintains shop floor quality presence; disposition in-process materials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or cell ... with Environmental, Health, and Safety personnel, Product Development, and Quality /Manufacturing personnel. Independently makes appropriate and compliant GMP … more
- Aequor (Thousand Oaks, CA)
- …by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout Ensure ... regulatory inspections Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining business metric… more
- Aequor (Devers, TX)
- …Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger ... through quality review and approval of Investigations and Corrective Actions....is preferred. Advanced Level of relevant experience in a GMP , GCP, or GXP with at least 8 years… more
- Merck & Co. (Rahway, NJ)
- …environments), with a minimum of one (1) year experience in Quality Assurance /Auditing/Pharmacovigilance.Excellent interpersonal skills, ie, ability to build ... If so, then this is the opportunity for you!Responsible to support PV Quality System audits our company's Animal Health own sites/entities, CROs and system audits.… more
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