- Bristol Myers Squibb (Summit, NJ)
- …+ Review and approve Standalone actions. + Contribute to deviation management procedure improvement. + Ensure appropriate CAPAs are generated to increase ... adheres to all BMS behaviors and values. + Must have knowledge on the review of deviation investigation and CAPA. + Must have knowledge on how to perform Root… more
- Actalent (Severn, MD)
- …meetings internally and with CDMO to provide updates on deviations. * Review deviation and associated technical reports and ensure investigation reports ... individual contributor will be part of team focused on review and management of major and critical deviations. Primary...are technically justified. * Participate in major and critical deviation root cause analysis on site. * Coach CDMO… more
- Lilly (Indianapolis, IN)
- …for the training program associated to deviation system and may leads deviation review boards, participates in deviation assessment review ... support data, CAPA establishment and effectiveness. + Coach the deviation review board: review of... assessor and approver. Can act as a technical reviewer for deviation investigations and analytical investigations.… more
- Actalent (Vernon Hills, IL)
- Job Title: QC Chemistry Data ReviewerJob Description As a QC Chemistry Data Reviewer , you will perform reviews and investigations related to QC chemistry analysis of ... investigations, and maintaining laboratory safety and practices. Responsibilities + Review test data, calculations, and results for accuracy and completeness.… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator II in Albuquerque, NM Summary: Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written report contains technical merit… more
- ManpowerGroup (Cambridge, MA)
- **Pharmaceutical Deviation and Investigations Writer** Our client in **Cambridge, MA, Kendall Square** is looking for hardworking, motivated talent to join their ... Friday (multiple shifts available )** **Job Description:** The Senior Deviation /Investigation Writer is responsible for performing GxP investigation activities and… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator III in Albuquerque, NM Summary: The Quality Deviation Investigator III plays a crucial role in overseeing and executing highly ... study + Minimum of five (5) years' related quality deviation experience + Experience with deviation or...in a team environment + Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents… more
- Kelly Services (Juncos, PR)
- …Amgen systems Knowledge: a. MAXIMO - Owner (RSO) b. CDOCS - Editor, Owner, Reviewer , Approver, Data Verifier c. QMTS - Deviation Initiator and Owner, Change ... implementation plan development & presenter * URS's, RD's, DS's reviewer / approver /owner * Maintenance Master Package (MMP)...the operation with an extensive downtime * Perform or review equipment / system Root Cause Analysis investigations *… more
- Interstate Blood Bank (Vista, CA)
- …Information Reports; generate and prepare associated customer notifications. + Performs review of Deviation Reports and associated documentation to ensure ... and files including but not limited to: Facility licensure, Error & Accident ( Deviation ) Reports, Deferred Donor List (DDL), Viral Marker Data Forms, Monthly Plasma… more
- Bristol Myers Squibb (Warren, NJ)
- …for review and approval activities. + Serve as author or technical reviewer of appropriate departmental procedures. + Review documentation as required by ... interpret , apply Global . + Advanced knowledge if investigation writing, CAPA and deviation management. + Knowledge of Sample Management and QC operations in a cGMP… more
- Lilly (Indianapolis, IN)
- …organization for deviation reduction and backlog prevention initiatives. + Chair the Deviation Review Board / Change Review Board + Analyze process/unit ... (both theoretical and practical), problem solving, project management, and deviation resolution. + Related experiences with troubleshooting bio-purification and… more
- Kelly Services (Oklahoma City, OK)
- **Tech** **nical** **Writer (GMP)** **Batch Record Review & Deviation Investigation** **Location** : Hybrid/Oklahoma City, OK **Job Summary** : We are seeking an ... You will also serve as the point person for managing and completing deviation and Corrective and Preventive Action (CAPA) paperwork. **Key Responsibilities** : +… more
- L3Harris (Cincinnati, OH)
- …/ customer. Review shipping documentation to ensure quality requirements compliance. Review waivers and deviation as required. + Coordinate with Government / ... replace some of the education requirements. Essential Functions: + Review the purchase order, contract, and specification to determine...areas. + Provide input and guidance as a peer reviewer of inspection plans and other contract line items.… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …and approval in QC inspection methods as needed. + Act as Change Review Board chairperson and Quality reviewer /approver for change management activities. ... established procedures. Provide quality engineering support in the areas of deviation management, change control, auditing, quality trends, quality costs, training,… more
- ThermoFisher Scientific (Richmond, VA)
- …compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation . + Organizes, schedules and supervises laboratory resources for group's ... project activities and updates project status. + Responds to client questions and needs, coordinates client communication and records meeting minutes. + Assists group leaders in their responsibilities. + Assists in preparation and implementation of PPD/client… more
- ThermoFisher Scientific (Greenville, NC)
- …procedures, training documents, and forms of moderate to high complexity + Perform quality review and approval of deviation and change control of moderate to ... in RAPID event response and provides quality guidance for deviation events + Advance deviation events to...moderate to high complexity + Perform quality batch record review + Aid in identification of continuous improvement opportunities;… more
- Bristol Myers Squibb (Summit, NJ)
- …by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows ... profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous… more
- Bristol Myers Squibb (Summit, NJ)
- …business records. Execute/perform LIMS, MRP or Electronic Batch Record review for inventory management documentation following ALCOA+ principles. + Understand ... profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous… more
- BeiGene (Hopewell, NJ)
- …technology transfers, troubleshoot process and equipment defects, perform deviation /investigation root cause analysis and impact assessments, support regulatory ... reliable and compliant execution of DS and DP cGMP operations ( deviation evaluation, process monitoring, change management), drive process optimization, and enable… more
- Bristol Myers Squibb (Summit, NJ)
- …by the team. Execute/perform batch record reviews (BRR) or Electronic Batch Record review by exception and ensure that all documentation produced by the team follows ... profiles for all new hired staff and administering the performance review process, differentiating performance, giving recognition when deserved and continuous… more