- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities: Ability to work… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in ... product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist… more
- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Senior ... the Drug Product area of the business. Responsibilities Reporting to the Quality Assurance Organization, will independently manage project assignments.Ensure all… more
- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status ... I. Department Overview: The Quality Assurance Department is responsible for...for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas ... in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance . required Experience Qualifications4 or More Years Strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical ... functions. Support the annual Quality Plan for Global Medical Affairs Quality Assurance , PVQA strategic plans and the tracking of Key Quality Indicators… more
- Catalent (St. Petersburg, FL)
- …employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the… 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 ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Aequor (Bothell, WA)
- Job Description: PURPOSE AND SCOPE OF POSITION: This position reports into the Quality Assurance department and is responsible for assisting with the ... Eight (8) or more years of relevant work experience in pharmaceutical quality operations, quality assurance , quality systems, and/or IT compliance role… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance ... to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as ... expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business ... DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review… more
- Aequor (Thousand Oaks, CA)
- …required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of ... responsibility FUNCTIONS: 1.Responsible for hiring, training, supervising and performance management of staff. 2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg.… 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 ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Tech Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and ... service disruption is required.- Strategic Planning- Under the guidance of the Manager develop and implement business operational strategies that align with the… more
- Aequor (Thousand Oaks, CA)
- …by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout Ensure ... a ideal candidate for this role NOTES FROM HIRING MANAGER : Looking for hands on *STRONG* engineer experience with...Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... Manager is requesting candidates college GPA in the...data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas (eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, collaboration, ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... least 5 years of enterprise-level governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC),… more
