- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality… more
- Repligen (Waltham, MA)
- …extensive support with document writing, document revisions, and handling investigations . Must have thorough understanding of Good Documentation Practices (GDP), ... identification and review and approval of deviation investigations and Out of Specifications (OOS) results, able to perform root cause analysis and generate… more
- Aequor (Davie, FL)
- …personnel interfaces. Perform and support Process and Product Quality investigations including implementation of corrective actions (CAPAs). Ensure full compliance ... write reports, business correspondence, and procedure manuals, change controls, investigations , qualification documents, etc. Ability to effectively present information… more
- Novo Nordisk Inc. (Durham, NC)
- …accordance with cGMP, NNPILP and corporate policies. While posted as an Associate Manager , we are seeking candidates with leadership experience for a growing team ... is onsite. Monday - Thursday 10 hr day shift schedule. Relationships Senior Manager . Essential Functions Lead team in successful execution of QC and Stability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… 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
- Aldevron (Miami, FL)
- …Aldevron's manufacturing processes, process optimization, new equipment and material investigation and onboarding, and support of Aldevron's Automation initiatives. ... of the Automation and Process Engineering team and report to the Manager , Process Engineering and Automation responsible for Automation and Manufacturing related… more
- Aequor (Seattle, WA)
- …Business HoursHybrid: (50%&plus days onsite required, days of week are flexible)Job ID: 62721Per manager , the Top 3 - 5 Must Have's a candidate should have are:Top ... solutions.Provide necessary technical analysis to support impact assessments and investigations .Function as a subject matter expert for autologous T-cell therapies… more
- Aldevron (Miami, FL)
- …a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method ... testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Support deviation investigations (eg, Out of Specification (OOS), Quality Events) by providing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS ... systems. Relationships Reports to: Manager API Manufacturing Number of subordinates with direct/indirect referral:...equipment Support activities in other departments as instructed by manager Performs all job duties and responsibilities in a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for HR processes as assigned Provide employee relations support by conducting investigations and providing appropriate guidance to drive manager consistency and ... compliance in handling performance management Provide support for individual development plan execution and assessing & establishing plan of action in relation to employee opinion survey results Participation in candidate selection, exit interviews & turnover… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …at our West Lebanon, NH bio-production facility. Relationships Reports to: QC Manager Essential Functions Liaison between Manufacturing and QC for the coordination ... with the ability to manage Change Controls Support deviation and CAPA investigations and corrective actions Support of Health Authority inspections Support area… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …policies, quality systems, and cGMP requirements.Support manufacturing investigations , create/revise operational procedures, including manufacturing work ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Resolution (with appropriate escalation as required). Resolve Technical Issues ( Investigations , CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment… more
- Cytiva (Muskegon, MI)
- …the Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department located in Muskegon, ... (CSV) protocols and/or Plans and Reports.Assist and approve deviation investigations , corrective and preventative actions (CAPAs), process improvements related to… more
- Cytiva (Miami, FL)
- …validation, providing training to teams, and participating in audits and investigations , all while ensuring compliance with industry standards and regulatory ... requirements.This position reports to the Contamination Control & Sterility Assurance Team Manager and is part of the Contamination Control & Sterility Assurance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions ... performance of building systems At the direction of the functional area manager (FAM), develop and maintain Key Performance Indicators (KPI) metrics Researches a… more
- Merck & Co. (Durham, NC)
- …Carolina facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate ... Practice to include the sharing of best practices in validation and investigation activities. Support creation of departmental budget and monitor actual performance… more
- Raytheon (Tucson, AZ)
- …one- or two-week duration.Ability to obtain a Single Scope Background Investigation (SSBI) security clearance.Ability to obtain and maintain additional program ... minimum of Eight (8) years of relevant experience.Cost Account Manager (CAM) experience and certificationPlatform Integration/Flight Test experienceIntegrated Product… more
- Raytheon (Tucson, AZ)
- …serving as a Responsible Engineering Authority (REA), Control Account Manager (CAM), and/or Integrated Product Team Lead (IPTL)Supplier management for ... analysis of design conceptsExcellent written and verbal communication skillsFailure investigation , root cause identification, and corrective action implementationFamiliarity or… more
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