- Merck & Co. (Durham, NC)
- …required to successfully support the QC laboratory Team to include the following: Quality Manager overseeing analytical testing and personnelLead the team and ... responsible for using principles of our Company Production Systems, Lean Laboratories, and cGMP requirements in the laboratory.- The Manager will manage the team… more
- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the ... Laboratory Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU… more
- Merck & Co. (Durham, NC)
- … activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management ... as required.Direct support of regulatory inspections and audits.Direct support of validation activities and all other associated Quality functions.Other duties… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both ... of his/her group.Job ResponsibilitiesWrite and Implement Standard Operating Procedures according to cGMP and cGLP.Assist in validation of new test methods for… 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 ... with relocation assistance eligible for selected candidate. Relationships Reports to: Manager of cLEAN & Training Number of subordinates with direct/indirect… more
- Houston Methodist (Houston, TX)
- …time effectively and prioritize daily tasks. **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Assists Quality Assurance Manager , cGMP Core Director and/or team ... experience in the biotechnology or pharmaceutical industry with exposure to cGMP manufacturing operations + Experience performing equipment validation … more
- Fujifilm (College Station, TX)
- **Overview** The Quality Assurance (QA) Manager , QA Validation , will be responsible for the review and approval of commissioning/qualification/ validation ... validation experience. + 4+ years of supervisory experience. + 4+ years of cGMP experience. + Single Use and Process Validation preferred. + Experience with… more
- PCI Pharma Services (Philadelphia, PA)
- …and coordinates resources for protocol execution. + Collaborates with the site commercial Validation Manager for any validation overlap. + Assures regulatory ... network to pioneer and shape the future of PCI. **Summary of Objective:** Validation /Sterilization Manager is responsible for qualification, validation , and… more
- West Pharmaceutical Services (Scottsdale, AZ)
- Sr. Manager , Process Validation Requisition ID: 68535 Date: Jan 16, 2025 Location: Scottsdale, Arizona, US Department: Engineering Description: At West, we're a ... is responsible for contributing to the development and implementation of the validation engineering strategy for West Global Technical Operations whilst ensuring the… more
- Eurofins (Charlotte, NC)
- …areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Position Summary Eurofins BPT ... Sales Manager to join our team, focusing on facility validation and environmental monitoring solutions for the biopharmaceutical and medical device industries.… more
- PCI Pharma Services (Madison, WI)
- …for validation and deviation impact. * Propose corrective actions to validation manager and appropriate departments to implement the required changes. ... The Validation Engineer I performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract manufacturing… more
- Fujifilm (College Station, TX)
- …Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA ...and site SOPs to ensure regulatory compliance. **Reports to** Manager , QA Validation **Work Location** College Station,… more
- PCI Pharma Services (Rockford, IL)
- …pioneer and shape the future of PCI. **Summary of Objective:** The Director of Validation is responsible for oversight of all validation and calibration efforts ... Services. Major responsibilities include the establishment and maintenance of PCI Pharma's validation strategy, policies and Master Validation Plan (MVP), as… more
- Fujifilm (College Station, TX)
- **Overview** The Quality Assurance (QA) Specialist II, QA Validation , under general direction, will be responsible for review and/or approval of basic and ... System improvements; Acting as a QA liaison internally. **Reports to** Manager , QA Validation **Work Location** College Station, TX **Company Overview**… more
- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete project. + Primary contact for quality validation activities and managing expectations. + Reviews and interprets ... and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager . + Investigates ...protocols. + Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11 and Annex… more
- PCI Pharma Services (Bedford, NH)
- …pioneer and shape the future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation Engineer III/IV is ... Validation (PV) and Revalidation (RV) in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. These Process… more
- AbbVie (North Chicago, IL)
- …Section Manager , this individual will participate in the implementation of the Validation quality program at the plant under minimal supervision. Level of ... new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation . + May supervise contract … more
- Danaher Corporation (Fargo, ND)
- …a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation ... experience in a life sciences company + Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and… more
- Merck (Durham, NC)
- …required to successfully support the QC laboratory Team to include the following: + Quality Manager overseeing analytical testing and personnel + Lead the team ... principles of our Company Production Systems, Lean Laboratories, and cGMP requirements in the laboratory. The Manager ...of regulatory inspections and audits + Direct support of validation activities and all other associated Quality … more
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