- Novo Nordisk Inc. (Boulder, CO)
- …control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible ... and/or in collaboration with global colleagues. Relationships Reports to the Director, Quality Assurance . Regularly interfaces with multiple NN global Quality… more
- Merck & Co. (North Wales, PA)
- …Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership… 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 ... impact and effective corrective actions and review of investigations.Serve as a technical subject matter expert (SME) in selected quality systemsProvides support… more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.Essential ResponsibilitiesPerforms Quality Assurance (QA) audits, inspections (internal/external), and ... role/operations Not less than two (2) years' experience in GLP/GCLP quality assurance (QA)Experience working in biotech, pharmaceutical, CRO/CMO, or… more
- Insmed Incorporated (Bridgewater, NJ)
- …follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC lab and to ensure ... in other departments to increase the overall effectiveness of the Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical… more
- Catalent (San Diego, CA)
- …work for scientific accuracy and compliance.Collaborate with other departments to troubleshoot technical issues.Collaborate with Quality Assurance and ... studies to determine if methods are suitable for transfer to Quality Control.Communicate results both internally and externally through oral and written… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the ...of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is required. A minimum… more
- Catalent (St. Petersburg, FL)
- …to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for...highest integrity, in partnership with Catalent St. Petersburg's internal technical departments. This position is expected to serve as… more
- Catalent (St. Petersburg, FL)
- …site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited ... Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site.… 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 ... front line support to address and resolve manufacturing issues.Key Responsibilities Provide Quality Oversight and technical expertise to the Technical … more
- Merck & Co. (Rahway, NJ)
- …holder through the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable ... industry best-practicesExperience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance Performs ... and write up Deviations events utilizing Root Cause Analysis Utilize the quality system to implement changes associated with technical operations, engineering,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance Knowledge of cGMP regulations ... other departments or outside contractors/vendors to complete tasks Supports and/or owns technical and quality investigations, CAPAs and corrections Develops and… more
- Merck & Co. (Rahway, NJ)
- …concepts.Hands on experience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... process.Responsible for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality Control and ... of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. Minimum of 4 years of...is required. Minimum of 4 years of experience in Quality Assurance related to manufacturing is required… more
- Merck & Co. (North Wales, PA)
- …Strong listening skills.Demonstrated sound understanding of related fields (eg, manufacturing, analytical, quality assurance ) and the ability to be creative and ... focus on compliance.May need to manage or mentor junior team members.- Technical Skills:Proven experience in critically reviewing detailed scientific information and… more
- BioAgilytix (Durham, NC)
- …you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance (QA) audits, inspections (internal/external), and monitoring ... role/operations Not less than two (2) years' experience in GLP/GCLP quality assurance (QA)Experience working in biotech, pharmaceutical, CRO/CMO or… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with an interdisciplinary team that includes but is not limited to quality assurance , quality control, operations, engineering, maintenance, calibration, ... safety, supplier quality , technical services, subject matter experts, and quality approvers to ensure appropriate and timely determination of scope,… more
