- Novo Nordisk Inc. (Boulder, CO)
- …Q7, & ISO regulations, guidelines, and applications of cGMP 's within Quality Control laboratory Demonstrated knowledge of pharmaceutical industry ... Manager to support the successful start-up of the Quality Control laboratory supporting phase...related field of study and 7+ years of QC lab experience required Minimum two or more (2+) years… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and ... protocols, completed assay data and reports primarily for the quality control laboratories.Key Responsibilities Be responsible for...QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development, ... leadership in lean lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and… more
- Aequor (Swiftwater, MN)
- This position supports the execution of routine testing in the Quality Control Microbiology laboratory while strictly adhering to site work instructions, ... Federal Regulations, cGMP , and Pasteur policies and procedures. This position requires...regulatory guidance. Participation in various and assigned phases of Quality Control testing. Duties may include (but… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP , cGLP, documentation) when performing the… more
- AUROBINDO (Durham, NC)
- …this a healthier world to live in.Job OverviewThe QC Supervisor focused on the Quality Control Laboratory , offering project and task management along with ... protocols, in-house SOPs, and testing procedures.QUA ResponsibilitiesLeading a quality control team and managing associated lab focused on Aurolife… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, document control .Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to ... quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP , USP, and CDR rules, and guidelines), and ensure...and provide new product support.Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... applicableThis role will foster a collaborative relationship with manufacturing and laboratory personnel focused on high quality systematic investigations,… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance ... Ensure individually assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. Provide QA… more
- Novo Nordisk Inc. (Boulder, CO)
- …developing scalable processes for oligonucleotides. Ensure process strategies developed at laboratory scale can achieve control limits and specifications ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...review of technical reports and protocols in support of cGMP activities. Serve as the technical expert supporting the… more
- Merck & Co. (Rahway, NJ)
- …process development in large molecule downstream processing including lab -scale process development and optimization, in-process assay support, and ... process scale-up/scale-down model development.Supporting the hands-on execution of lab -scale experiments and authoring associated technical reports and documents.Collaborating… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …will assist leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and ... to Microbiology management, (ie, QC-Microbiology Supervisor) and will provide both laboratory and/or environmental monitoring leadership as part of the Microbiology… more
- Novo Nordisk Inc. (Durham, NC)
- …with cGMP , NNPILP and corporate policies. Relationships Senior Manager, Quality Control Chemistry. Essential Functions Lead team in successful execution ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...training planning and development of technicians and analysts Review lab generated data to ensure data integrity and timely… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Organism Identifications to the genus and species level. Perform Growth Promotion/ Quality Control Testing of Microbiological media and/or materials used ... Position Summary The Microbiologist I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and… more
- Merck & Co. (Rahway, NJ)
- …Sterile Product Development (SPD) department provides technical process leadership and laboratory capabilities in support of clinical and commercial stage pipeline ... shear, freeze-thaw, pumping, filling) impact protein stability, aggregation, and product quality .Deploy portfolio of modeling and in silico tools to drive superior… more
- Merck & Co. (Rahway, NJ)
- …and confined space entry.Lockout/Tagout and Energy Control Procedure implementation and developmentEmergency Repairs/TroubleshootingCalibration/Routine Preventative ... representatives, and other team members to ensure a safe work environment, the quality and safe delivery of clinical supplies, and an optimized work plan. A… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control (QC)...GLPs, GDPs). Experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work ... internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control ...current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is responsible for… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control Lab TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... laboratory tests as appropriate. + Complies with any quality control policies and procedures and maintains... laboratory experience, knowledgeable in use of specialized laboratory equipment. Working knowledge of lab procedures,… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control (QC) Specialized Laboratory...Practices ( cGMP ) facility. The cGMP Quality Control (QC) Specialized Lab ... TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP - Quality - Control --QC--Specialized- Laboratory -Technician\_REQ20159957/apply) Keck School of Medicine Los Angeles, California… more
