- Aequor (Thousand Oaks, CA)
- …industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr . Associate...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Merck & Co. (Rahway, NJ)
- …process and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is a ... for the benefit of patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS… more
- Merck & Co. (Rahway, NJ)
- …IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance ( QA ), Resource Planning, Service Delivery, ... SLA Management, Software Configurations, Software Development Life Cycle (SDLC), Stakeholder Communications, Strategic Planning, Strategic Thinking, Testing {+ 1 more}-Preferred Skills:Job Posting End Date:08/6/2025 *A job posting is effective until 11:59:59PM… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control, quality assurance , and manufacturing ... judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and… more
- Aequor (Thousand Oaks, CA)
- …ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance : Ensure all data management activities comply with ... and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc. Determine key… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/ QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am ... from interdepartmental sources.ResponsibilitiesWorks with subject matter experts, area managers and senior level Document Control and QA -personnel to properly… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance ( QA )/ Quality Control (QC)/Regulatory ... New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Developing quality and strategic objectives and strong business understanding of… more
- Repligen (Waltham, MA)
- …with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve as ... This leader will be responsible for managing the site quality assurance team which includes all day-to-day...based in Waltham, MA and will report to the Sr . Director, Quality - Quality … more
- Merck & Co. (Upper Gwynedd, PA)
- …related pharmaceutical operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such ... Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/ Sr Principal Scientist in Pre-approval Pharmaceutical… more
- Actalent (Wichita, KS)
- …codes and specifications related to design requirements. Review design drawings for quality assurance within scope, budget, and schedule. Perform project tasks ... and assignments within budgeted hours and deadlines. Compute calculations for layouts, equipment, wiring diagrams, and schematics. Ensure revisions of project drawings, plot files, and project-related information are stored in a logical and well-structured… more
- Granules Pharmaceuticals (Chantilly, VA)
- Job Type Full-time Description Job Summary The Sr . Quality Assurance Associate, Compliance & Vendor Management position ensures compliance with cGMP and ... agreements. Any other activities as requested by management. Reports to Quality Assurance , Director Internal/External Contacts N/A Requirements Knowledge &… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... in vendor agreements. Ability to work cross-functionally and influence senior stakeholders. Excellent analytical, financial, and strategic thinking skills.… more
- Aequor (Thousand Oaks, CA)
- …management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Actalent (Madison, WI)
- QA Technician 3rd Shift The Quality Assurance Tech plays a crucial role in ensuring the highest standards of product quality and compliance. The majority ... log books. Issue batch records as needed. Essential Skills: Quality assurance expertise. FDA and GMP compliance...years of experience in a regulated industry (GMP/FDA/ISO). For Sr . roles, 5+ years of regulated industry experience. For… more
- Twist BioScience (South San Francisco, CA)
- …functional groups including Product Management, R&D, tech transfer, manufacturing, and QC/ QA .Leads and facilitates project meetings with an efficient and structured ... team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale and team commitments to goals and objectives by… more
- Flik Hospitality Group (Cincinnati, OH)
- …us achieve flawless operations. Key Responsibilities: Promote, implement, maintain, and verify Quality Assurance ( QA ) and safety reporting standards Provide ... career where you can flourish. Job Summary As a Quality Assurance Specialist at Flik, you'll play...non-compliance observations Work with managers to find solutions to QA challenges and crises Liaise with clients, senior… more
