- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What ... will review manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and support records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 of those ... in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the...systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality… more
- Merck & Co. (North Wales, PA)
- …the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of ... execution for successful delivery across various teams and vendor partners to meet product line objectives with high quality , timeliness, and within budget /… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality ... Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a ... Quality Assurance Agreement system which provides a...and evaluate data for critical operations related with Annual Product Reviews. Manages the completion of stability studies program… more
- Insmed Incorporated (San Diego, CA)
- …systems for stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance , Manufacturing and CMOs, Material Management, and other ... fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory...in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research… more
- Merck & Co. (Rahway, NJ)
- …performance of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance :Ensure that all activities ... sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership… more
- Merck & Co. (Rahway, NJ)
- …through the entire product lifecycle.Key areas of focus include (1) the assurance of deliverable quality and process compliance , (2) effective ... and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance .Ability to anticipate stakeholder and regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to 20/30 (Snellen) or betterWorks in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or cell therapy. A minimum… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance standards in the healthcare and digital health space. Establish quality assurance processes and protocols to support implementation Budget ... quality standards Familiarity with healthcare regulatory requirements and compliance standards related to digital health Excellent communication and presentation… more
- Aequor (Devers, TX)
- …preferred. Minimum 4 years relevant work experience, with experience in a Quality Assurance role. QUALIFICATIONS REQUIRED Equivalent combination of education and ... teams. Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality , and compliance environments. Prefer to also have knowledge of GMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... quality metrics while ensuring high quality and complaint product supply.Key ResponsibilitiesSupport compliance activities for site Quality … 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 ... and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company… more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting processes ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Candidate must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance , clinical quality , ... by ensuring inspection readiness within facility.Provide oversight for trending of quality compliance metrics.RequirementsA minimum of a Bachelor's Degree in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Lead the definition of solutions… more
- Aequor (Thousand Oaks, CA)
- …The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance . The position will support ... projects, including validation protocol development and execution Experience with combination product / medical device quality systems verification Process… more
