- Aequor (Thousand Oaks, CA)
- …an equivalent level of biopharmaceutical experience with responsibility in a quality , analytical development, process development, or manufacturing environment- ... Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution… more
- Aequor (Vacaville, CA)
- …CA. In this role, you will provide essential support to the Supplier Quality Management process , ensuring compliance with cGMP and global requirements. Key ... We are seeking a highly motivated and experienced Contract Supplier Quality Support Specialist to join our team in Vacaville,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process , define strategies to lead to the development and ... implementation of quality improvement initiatives across the organization.This role will focus...of technical expertise, influential skills, and a passion for process optimization to deliver measurable results through the engagement… more
- Aequor (Vacaville, CA)
- …in Vacaville, CA. In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring ... Support the implementation, execution and maintenance of the PQS integration and Quality Documents in Veeva at the Vacaville site. Support PQS integration by… more
- Merck & Co. (Rahway, NJ)
- …within biopharmaceuticals.Planning and facilitating high risk and highly complex Quality -related process reviews and/or investigations under minimal ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Merck & Co. (Durham, NC)
- …specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance.Required Experience and Skills:Strong Batch ... approve Performance Qualification documents pertaining to environmental monitoring and process qualification.Provides Quality input, direction, and approval of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordination and execution of manufacturing equipment maintenance, improvement programs, and quality responses for process equipment as needed. Relationships ... of manufacturing related equipment In partnership with Senior Technicians, Process Engineers and/or Manufacturing Technicians assist with trouble shooting, repair… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate in the... validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with PSS Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance and ... review, agent screen recording review Develop, execute and refine process for oversight of Vendor's quality check...and refine process for oversight of Vendor's quality check function Track and report vendor performance and… more
- Aequor (Framingham, MA)
- …clearance, and leachable and extractables. Understand cGMP concept and familiar with quality and regulatory framework. Proficient in process data analytics ... improved. Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and influences internal management and study level stakeholders on risk-based quality management principles, process improvement, metrics design and application ... position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements… more
- Merck & Co. (Durham, NC)
- … control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, ... Quality Management System focusing on batch record review, process /aseptic observations, critical site review, critical alarm management, environmental monitoring… more
- Aequor (Devers, TX)
- …of Site Engineering (Maintenance and Metrology activities), Supply Chain/Warehouse, Laboratories ( Quality Control and Process Development), or Cell Therapy ... and distribute EHS reports and records as assigned.Create and maintain a systemic process to ensure workflow timelines for EHS events and action plans are adhered… more
- Tris Pharma (Monmouth Junction, NJ)
- …(OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, ... Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS)… more
- Genmab (Plainsboro, NJ)
- …compensation processing.Proactively monitors and strives to maintain high levels of quality , accuracy, and process consistency in field incentive compensation ... responsible for owning the end to end Incentive Compensation process from design and implementation to payouts and leadership...annual awards trip and promotion criteria based on performance.Manage quality controls and quality assurance in the… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability to turn strategy ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Genmab (Plainsboro, NJ)
- …Access, and external customers.Proactively monitors and strives to maintain high levels of quality , accuracy, and process consistency in the US Sales & Marketing ... or display opportunities, where applicable.Promotional Materials review: Manage the process for multiple brands, in conjunction with alliance partners, brand… more
- Aequor (Framingham, MA)
- …1st Work Schedule: 9 - 5 EST; Mon - Fri Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. ... investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw… more
- Aequor (Oceanside, CA)
- …knowledge needs to be deep in Site Operations bioprocessing, document revision, the Quality / GMP change control process , and project management capabilities. Job ... process . Perform Change Owner responsibilities for Site Operations by managing process area and system change records including: quality actions, technology… more
