- Repligen (Waltham, MA)
- …with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance .Maintain internal and external audit schedules; serve as ... the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Aequor (Thousand Oaks, CA)
- …and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance : Ensure all data management activities comply ... cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk-based Quality Management etc.… more
- Eisai, Inc (Raleigh, NC)
- …(MBRs)Assist with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation, and reporting of ... Eisai Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with… more
- Aequor (Houston, TX)
- …and knowledge with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate ... M-F 1st Shift on-site 5x/week Responsible for tracking, management , and completion of Supply Chain Quality...to work well within a team. Routine interaction with Quality Assurance and other Quality … more
- Repligen (Hopkinton, IA)
- …and make real-time adjustments to meet production targets.Inspect products for quality assurance and report defects or inconsistencies.Communicate effectively ... helps in performing all tasks involved in the production of Repligen's fluid management products including production tasks such as kitting of parts, cutting of… more
- Beyond SOF (Ashburn, VA)
- …our Federal customer, the QA/ Change Control Coordinator supports change management and Quality Assurance tasks related to projects to upgrade ... impact analysis, risk assessment, and change scheduling. *Develop and maintain change management artifacts such as change records, change plans, and… 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 ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- Aequor (Thousand Oaks, CA)
- … when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in ... timely manner and elevating cross-functional customer concern to various levels of management as appropriate. Owning Change Controls in Trackwise, ensuring… more
- Merck & Co. (Rahway, NJ)
- …Solutions, Management Process, Management System Development, Problem Management , Quality Assurance (QA), Resource Planning, Service Delivery, ... Management , Business Process Improvements, Business Strategies, Business Technology, Change Controls, Computer Technical Support, Cost Management , Financial … more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Merck & Co. (Durham, NC)
- …a risk-based approach (Safety Regulations, Quality Assurance , Risk Management , Deviation Management , Product Release, Change Control).- Supply Chain ... 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
- Planet Pharma (Chicago, IL)
- Job Description The Quality Assurance Specialist position is responsible for Document and Training Management Programs. This will require working with our ... communications skills *Planning and Organizing *Interpersonal *Teamwork *Problem Solving * Quality Management *Judgement *Dependability *Ethics" To perform this… more
- Grand River Aseptic Manufacturing (Grand Rapids, MI)
- …in risk management . Regulatory knowledge of pharmaceutical manufacturing with GMPs, change control, risk management and quality by design. Must ... Quality , Service, Collaboration, Courage. Do you exhibit these...lives every day. Overview of this Position: The Sterility Assurance Validation Project Manager manages aseptic process simulation studies… more
- Eli Lilly and Company (Lebanon, IN)
- …environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance , etc.) Additional Preferences: In depth knowledge ... aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management . Key Objectives/Deliverables Understand the… more
- Spirax-Sarco Engineering (Wilmington, MA)
- Job Title: Client Experience Manager - Quality Assurance Location: WM USA - 37 Upton Drive Location Type: Remote Website: https://www.wmfts.com/en/ Group: ... Watson-Marlow is seeking a proactive, customer-focused Client Experience Manager- Quality Assurance (CEM) to support our top...to be successful in this role Bachelor's degree in Quality Management , Bioprocessing, Engineering, or a related… more
- Cedent (Pompano Beach, FL)
- Client is seeking an entry-level Quality Assurance / Quality Control Associate to support clinical manufacturing and drug development activities in a ... individuals looking to begin their careers in biotech, particularly in quality and regulatory compliance. Key Responsibilities: Receive and qualify incoming… more
- RSM Global (Charlestown, MA)
- …middle market globally, our purpose is to instill confidence in a world of change , empowering our clients and people to realize their full potential. Our exceptional ... looking for a dynamic PCR Manager to join our Assurance team. You will have the opportunity to work...the most challenging business cycles. Responsibilities: Provide timely, high quality client service that meets or exceeds client expectations… more
- KeyBank (Cleveland, OH)
- …Ohio About the Job As part of Key's second line of defense Compliance Risk Management function, the Risk Evaluation and Assurance Program (the "REA Program") has ... and/or testing concepts and apply those to testing, monitoring, issues management , and verification activities. The Senior Compliance Manager must exhibit strong… more
- cGMP Consulting (Philadelphia, PA)
- …Summary cGMP Consulting is seeking an experienced Contract Manufacturing Organization Quality Assurance Engineer with knowledge in packaging and labeling ... of study. 10+ years' experience in a GMP manufacturing environment, Production, Quality Assurance . Knowledge of FDA regulations. Advanced critical thinking and… more
