- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate ... audienceAt least 8 years' experience in the biotech/pharmaceutical industry in validation , quality management, process controls, and continuous improvement in… more
- Novo Nordisk Inc. (Durham, NC)
- …& perform verification activities for projects according to science & risk-based validation (SRV). Relationships Manager , Process Support - OFP. Essential ... revalidation & other validation activities for AP Author & review validation procedures, specifications & quality documents for accuracy & compliance Present… more
- Novo Nordisk Inc. (Boulder, CO)
- …worlds to develop new medicines for patients. The Position Novo Nordisk is seeking a Quality Control Manager to support the successful start-up of the Quality ... of US FDA, ICH Q7, & ISO regulations, guidelines, and applications of cGMP 's within Quality Control laboratory Demonstrated knowledge of pharmaceutical industry … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …best industry practices, application of principles, concepts, practices, standards, validation , and qualification within a cGMP manufacturing ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and reports, ... manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA/EU… more
- Merck & Co. (Durham, NC)
- …required.Other: Direct support of regulatory inspections and audits.Direct support of validation activities and all other associated Quality functions.Other ... Job DescriptionSpecialist, Quality Systems and Compliance (P2)- Night Shift Our...Specialist provides guidance/direction of resources and equipment pertaining to qualification/ validation and start up activities supporting the HPV expansion… more
- Novo Nordisk Inc. (Durham, NC)
- …process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with ... duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensure site compliance with Regulations,… more
- Merck & Co. (Durham, NC)
- …Ensure individually assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. Provide QA ... objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review...validation documentation as needed. May act as a Quality Risk Assessment Lead. - - Education Minimum Requirement:… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse and ... West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions… more
- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating ... internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract… more
- Element Materials Technology (Ann Arbor, MI)
- **Overview** Element Ann Arbor has an opportunity for a **Department Manager ( cGMP Testing)** to join our growing team in Michigan. In this role you will be a ... of conduct, and company policies and procedures. The **Department Manager ( cGMP Testing)** will provide leadership to...improvement. This is an exciting opportunity for an experienced Quality Control and cGMP Sample Analysis Leader… more
- Houston Methodist (Houston, TX)
- …and prioritize daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in ... defining quality policies. + Assists Quality Assurance Manager , cGMP Core...of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations + Experience performing equipment validation… more
- Actalent (St. Paul, MN)
- Validation Engineer Manager Validation & Qualification: + Develop and execute Facility, Utility, and Equipment Qualifications. + Develop and execute ... on-time completion. + Prepare and present technical reports, project updates, and validation metrics to senior management. Compliance & Quality : + Ensure… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- Eurofins (Philadelphia, PA)
- …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
- 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)
- …**Location:** Rockford - Linden Road **Reports to:** **Senior Director of Quality , Biotech Center of Excellence** **FLSA Status:** Exempt **Summary of Objective:** ... The Director of Validation , Bio-Tech CoE is...Subject Matter Expert (SME), and assure that customer requirements, cGMP requirements, and all foreign and domestic regulations are… more
- Novo Nordisk (Durham, NC)
- …& perform verification activities for projects according to science & risk-based validation (SRV). Relationships Manager , Process Support - OFP. Essential ... validation activities for AP + Author & review validation procedures, specifications & quality documents for... validation areas (equipment, cleaning, process, or computer validation ) preferred + Experience in cGMP documentation… more
- Danaher Corporation (Fargo, ND)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation ... . You will assist in representing the Analytical Method Validation team in matters related to analytical test method...Experience in technical writing and supporting investigations in a cGMP compliant Quality Control Laboratory setting. +… more
- Danaher Corporation (Fargo, ND)
- …for vital new discoveries worldwide. You will be a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation ... improve human health. This position is part of the Quality and Regulatory Affairs Department located in Fargo, North...and will be responsible for representing the Analytical Method Validation team as a subject matter expert (SME) on… more
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