- Novo Nordisk Inc. (Durham, NC)
- …duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance with ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...degree as appropriate Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the… more
- 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 ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… 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...schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance ... and could include all or some aspects of the Quality function.The Product Development QA Manager... Manager is responsible for the overall Quality Assurance review and approval of all… more
- Catalent (St. Petersburg, FL)
- … QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The ... the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment 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 Manufacturing Excellence Manager role is an...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality Control and ... treatment of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of...is required. Minimum of 4 years of experience in Quality Assurance related to manufacturing is required… 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 ... and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point...annual Quality Plan for Global Medical Affairs Quality Assurance , PVQA strategic plans and the… 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...Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon 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 ... knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed ... P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all...pushing and pullingAbility to travel WORKING RELATIONSHIPS: Reports to Quality Manager Interacts with employees within own… more
- BioAgilytix (Durham, NC)
- …a strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementMaintain ... all phases of our client services. As a Project Manager I, you will be the glue connecting our...functions to the actions required of an efficient and quality -driven project process. You'll experience a broad range of… 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business ... for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Non-GxP computer systems implementations in partnership with Global DX, and QA -CSV/eCompliance team members to ensure compliant, efficient and timely completion of ... for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business… more
- Aequor (New York, NY)
- …Minimum experience of 1-3 years in case management, utilization review and/or quality assurance Experience in episodic care, wellness care and counseling ... of adults Proficiency in use of electronic medical record keeping systems desirable BLS certification required Optional: Case Management and COHN-S certifications Major Responsibilities: Assist in coordination of clinical operations, including medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… 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 ...Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. Role… more
