- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project ... improvement projects. - Position Responsibilities Could Include: Reporting to the Quality Assurance Organization, will independently manage project assignments.… more
- Novo Nordisk Inc. (Durham, NC)
- …SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes. Relationships Manager, Quality Assurance . Essential Functions ... quality processes are compliant with regulations Authority for product release Quality oversight, review & approval of validation activities associated with… more
- Novo Nordisk Inc. (Durham, NC)
- …& QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions Ensure site compliance with Regulations, ... shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation ...provides quality oversight, review & approval of validation activities associated with minor changes to existing systems.… more
- 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 certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular… more
- Merck & Co. (Durham, NC)
- …that produce life-saving medicines and vaccines, including our HPV vaccines.The Quality Specialist provides guidance/direction of resources and equipment ... interprets client and/or customer needs to identify solutions. FUNCTIONAL EXPERTISE: The Quality Specialist will be responsible for comprehensive management of… 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 ... Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... Legend Biotech is seeking CQV Specialist (Contractor) as part of the Technical Operations...position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell… more
- Fujifilm (Thousand Oaks, CA)
- **Position Overview** The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to, ... CAPAs and change control records. The role will work closely with manufacturing, quality control, quality assurance , supply chain, engineering and facilities… more
- Curia (Rensselaer, NY)
- Senior Quality Assurance Validation Specialist in Rensselaer, NY Build your future at Curia, where our work has the power to save lives! Curia is a ... with matching contributions + Learning platform + And more! Summary The Senior Quality Assurance Validation Specialist assists with the validation … more
- Catalent Pharma Solutions (Harmans, MD)
- …and will house 8 CGMP manufacturing suites and cold storage warehousing. The **Lead Specialist , QA - Validation & Quality Engineering** is responsible for ... **Lead Specialist , QA Validation & Engineering** Catalent...medical device industry performing direct hands-on work in a Quality Assurance function **OR** + Bachelor's degree… more
- Fujifilm (College Station, TX)
- …reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance . The QA Compliance Specialist III, QA ... **Position Overview** The QA Specialist III, QA Validation , will be...of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering… more
- PCI Pharma Services (Philadelphia, PA)
- …pharmaceutical sciences, or related field. Experience: At least 3 years of experience in validation , quality assurance , or a related role in the ... pioneer and shape the future of PCI. Job Title: Validation Specialist Summary of Objective: The ...and attend off-site meetings. 4. Collaborate with engineering, operations, quality assurance , customers and other stakeholders to… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... other departments including, but not limited to: Information Technology, Operations, Engineering, Quality Assurance , and Product Development to provide a high… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …equipment used in the manufacture of drug product intended for human consumption. This validation group within the Quality Assurance department oversees all ... **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc....of relevant projects and their potential impact on product quality and GMP/GLP. The validation department is… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**...well as deviation notifications/investigations + Collaborating with IT, Automation, Quality Assurance and End Users to ensure… more
- Mentor Technical Group (Caguas, PR)
- …production staff to ensure operational consistency and effectiveness. + Coordinate with Quality Assurance and Engineering departments to ensure timely execution ... in Engineering or a related field. + Certifications in validation practices or quality management systems. + Experience with regulatory audits and compliance.… more
- The Greentree Group (Madison, WI)
- …of hands-on experience in communications system development, engineering testing & evaluation, quality assurance , or related field. + Experience and knowledge of ... Independent Verification & Validation (IV&V) Technical Specialist + A...recommendations for functional, technical, and/or process improvement. + Review quality control processes and identifying areas needing improvement. +… more
- Abeona (Cleveland, OH)
- JOB TITLE SPECIALIST I, QUALITY ASSURANCE - QUALITY OPERATIONS Department Quality Assurance - Quality Operations Reports To Supervisor, ... Quality Operations or above Ladder Level 2 DESCRIPTION Position Overview The Specialist I, Quality Assurance performs routine activities associated with… more
- Kelly Services (Arroyo, PR)
- **Kelly(R) Engineering** is seeking ** Validation Specialist ** for contract position at manufacturing client in **Arroyo,** Puerto Rico. If you're passionate ... topics to appropriate personnel. * May train others in Quality Assurance /GMP/FDA-QSR related topics, as a result...in Engineering Previous experience releated + TMV (test method validation ) + Creation SOPs + Protocols and reports on… more
- Colorado State University (Fort Collins, CO)
- Posting Detail Information Working TitlePSRL & OBRL Quality Assurance Specialist I Position LocationFort Collins, CO Work LocationPosition is fully ... Bioengineering Research Laboratory ( OBRL ) are seeking a Quality Assurance (QA) Specialist I...Services Duty/Responsibility + Review documentation in support of process validation and product review at all stages of regulated… more
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