- Merck & Co. (Millsboro, DE)
- Job Description Description: The Quality Assurance Specialist for Batch Release is responsible for the execution of release tasks and preparation of ... Final Product to market as well as supporting other Quality Assurance roles as needed. Specifically, the...products made for the EU Market. Contribute to or Lead Department Investigations, as needed utilizing the Reliance Deviation… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... Fully remoteResponsibilities: Coordinate Global Incoming Quality Process Operations to support Global Process Owner...Quality Process Operations to support Global Process Owner lead . Interface with IQA Network, various sites and business… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by...Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process… 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 ... needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... requirements in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous improvement efforts, Quality site… 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 ... Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision...in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to support Global Research… 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 ... outstanding opportunity for an enterprising data and analytics technology leader who will thrive in a dynamic environment and...data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient-specific, finished drug product batches by collaborating with all functions (including Quality Assurance , Quality Control, Operations, Vein to Vein, ... 5 years of relevant work experience in Operations, Supply Chain, or Quality Assurance experience within a cGMP environmentFacilitate cross functional discussions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at...role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure ... that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation, solution… 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 ... team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality ...Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... to complete the technology transfer for customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the… more
- Aequor (Louisville, KY)
- …4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. ... Candidate: Bachelors &plus 2 years of working experience. Labatory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma ... to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to end. Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission and compliance of all required DS documentation for quality control/ assurance , legal, finance, operational and educational requirements.Operates ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...OEDC metrics (ie KPIs, KQIs, and other speed and quality metrics) through the use of dashboards.Coordinates communication of… more
- Aequor (Louisville, KY)
- …What stands out on resumes - Experience working with a quality assurance organization, facilities engineering, a warehouse/factory environment, experience ... critical facility equipment and key computerized systems Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment… more
- BioAgilytix (Durham, NC)
- …budget.Workstream Coordination: Manage all internal BioAgilytix teams (lab operations, IT, quality assurance ) and external resources to ensure efficient project ... strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite planning, execution, and monitoring of the LIMS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... governance. Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs, cost, and… more
