- Tris Pharma (Monmouth Junction, NJ)
- …position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality ... quality functions and systems including, but not limited to: investigations , deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative… more
- Merck & Co. (Durham, NC)
- …equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning ... with minimal supervision.Responsibilities:Analyzes calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on… more
- Merck & Co. (Durham, NC)
- …Storage Facility (MMSF). This support position will focus on leading investigation of HVAC system excursions, engineering maintenance, design-system improvements and ... optimizations.- This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent… more
- Merck & Co. (Durham, NC)
- …equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning ... with minimal supervision.Responsibilities:Analyzes maintenance, equipment and calibration performance and work orders to identify trends with an emphasis on reducing… more
- Merck & Co. (Sacramento, CA)
- …lab(s) to support on time batch release.Additionally, this position will work directly with technical operations, quality, regulatory, microbiology, and analytical ... to ensure the accuracy and reliability of test results.Lead/support complex investigations and drive resolution of analytical technical issuesBuild and manage… more
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Rahway, NJ)
- …and Accurate (ALCOA) principles.Author technical reports, analysis certificates, investigations /deviation records, and SOPs. Perform data entry, data ... and author analytical reports or data summaries.Troubleshoot and lead any investigations associated with GMP testing through active collaboration with Device… more
- Aequor (Seattle, WA)
- …document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) ... solutions.Provide necessary technical analysis to support impact assessments and investigations .Function as a subject matter expert for autologous T-cell therapies… more
- Merck & Co. (Rahway, NJ)
- …pipeline.Support the formulation, process development, and scale-up activities, quality investigations and change management, and author GMP standard operating ... experience.Required Experience and Skills: Experience in leading and supporting quality investigations and change management and experience with quality systems also… more
- Aequor (Thousand Oaks, CA)
- …support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training ... multisite documents or in response to change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good… more
- Aequor (Davie, FL)
- …high level of technical expertise within a specialty field(s) and internalize work based on feasibility. ESSENTIAL AREAS OF RESPONSIBILITY All areas of ... personnel interfaces. Perform and support Process and Product Quality investigations including implementation of corrective actions (CAPAs). Ensure full compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position carries out routine QC testing and may support sampling, investigations , validations, projects and other related support activities for the manufacturing ... or method verification/validation activities Participates in deviations and laboratory investigations Update standard operating procedures with help Delivers training… more
- Aequor (Tampa, FL)
- Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of ... Support QC chemist to provide the method technology transfer and project preparation work , make sure the project runs on time and smoothly. Key Accountabilities… more
- Cepheid (Miami, FL)
- …an environment that fosters career growth and development.Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're ... reports and establish product shelf-life.Provide technical expertise for post market investigations and design changes, including documentation of investigations … more
- Merck & Co. (Rahway, NJ)
- …initiatives to enhance flexibility, efficiency, and compliance.Supports investigations and implementation of corrective/preventative actions.Mentors and trains ... and don & wear cleanroom protective gowning including respirators.Demonstrated ability to work and communicate both independently and as a part of a team.Preferred… more
- Merck & Co. (Rahway, NJ)
- …initiatives to enhance flexibility, efficiency, and compliance.Supports investigations and implementation of corrective/preventative actions.Positions are based ... and don & wear cleanroom protective gowning including respirators. Demonstrated ability to work and communicate both independently and as a part of a team. Preferred… more
- Aldevron (Miami, FL)
- …part of the analytical procedure life cycle. In this position, you will work collaboratively with cross-functional internal teams as well as clients to ensure test ... testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Support deviation investigations (eg, Out of Specification (OOS), Quality Events) by providing… more
- BioAgilytix (Durham, NC)
- …we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll ... to the validated systemResponsible for coordination of all appropriate deviations and investigations associated with the systemPerforms reviews of system events on a… more
- Merck & Co. (Rahway, NJ)
- …Device SME.-Partner with MDCP sites and internal stakeholders to support investigations related to supplier caused deviations and CAPAs.Integrate Purchasing Control ... knowledge of regulations listed above and be able to work in a team environment identifying gaps in the...detail and multi-tasking skills.Effective people skills and ability to work collaboratively across diverse teams and networks, able to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …safety policies, quality systems, and cGMP requirements.Support manufacturing investigations , create/revise operational procedures, including manufacturing work ... production task to execute and ensure compliance and successful completion of work -related tasks. Work closely with operations personnel on the production floor… more
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