- Aequor (Swiftwater, MN)
- Overview of the Position The Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues on ... PA USA. This is a hybrid position. Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by… more
- Merck & Co. (Durham, NC)
- …Previous investigation and CAPA experience, Batch Record Review, Validation IQ, OQ, PQ, Change Control . Has in-depth knowledge of cGMPs and domestic and ... Job DescriptionSenior Specialist , Quality Systems and Compliance (P3) Our company...input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs).- Author, review, and approve SOPs. Assume… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …alternate material sources, alternate BOM/recipes, etc. and collaborate on required change control deliverables where applicable.Provide expert-level support for ... treatment of multiple myeloma.Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role… more
- Merck & Co. (Durham, NC)
- …- KnowledgeExperience with on-the-floor cGMP manufacturing supportAuthored complex process change control or deviation investigationsExperience with in person ... Job DescriptionWe are seeking a Growth and Improvement minded Validation Specialist that can help drive our Strategic Operating Priorities.Invent - Pursue the Most… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …managementProficient with Manufacturing Execution System (MES)Quality Management knowledge, including Change control , Deviation, and CAPA's.EHS and regulatory ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Maintenance Specialist , Cleaning Services as part of the Technical Operations team based in… more
- Novo Nordisk Inc. (San Antonio, TX)
- …disease achieve greater health outcomes. If you are passionate about being a force for change , not afraid to take risks and challenge the status quo, and are looking ... obesity to maximize sales within an assigned territory. The Obesity Care Specialist (OCS) must achieve sales goals by implementing marketing and sales strategies… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Risk Assessment Specialist as part of the Technical Operations team based in Raritan, NJ. ... the risk, evaluate the risks and work resources to control the risks based on failure analysis resultsPlan and...well as problems and solutions, and implement and manage change when necessary to meet risk assessment outputsLead issue… more
- Aequor (Bothell, WA)
- …problem, and asset management PURPOSE AND SCOPE OF POSITION:The Benchtop Support specialist position will be responsible for providing IT support in our Digital ... site and global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT, validation, and… more
- Aequor (Waltham, MA)
- This candidate will support Doc Control and Quality Systems departments. Required to be onsite for support as needed. Perform the following activities: Document ... Control : Run Daily Report - QualiPSO Veeva Documents Accept/Closed...DC support Quality Systems: 1. Support and manage TPCN Change Controls (CC) a. This role will require ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. ... assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring Risk Assessments, FMEAs,… more
- Aequor (West Greenwich, RI)
- …of cGMP processes, procedures, assays, documents and records, including nonconformances, CAPAs, change control records and validations. May execute these tasks ... Supports Continual Improvement initiatives, programs and projects Ensures that changes that could potentially impact product quality are assessed according to procedures Ensures that deviations from established procedures are investigated and documented per… more
- Merck & Co. (Durham, NC)
- …system(s) remain in a validated status (eg, problem and incident management, change control , periodic review, investigations, backup/restore, System Use and ... Administrative SOPs (including sufficiently detailed electronic data review/audit trail review instructions for users), disaster recovery plans, business continuity plans). Review processes and support documentary evidence to verify that compliance activities… more
- Aequor (Thousand Oaks, CA)
- …etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records. Site performance monitoring: Report contract site performance metrics ... to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance… more
- Aequor (Thousand Oaks, CA)
- …process in compliance and alignment. Complete and approve multisite procedures, deviation, change control and other quality records to support RM Network. ... Candidate must have strong leadership skills, communication skills, and the ability to approach issues from a strategic perspective. This includes the ability to translate strategy into challenging, actionable objectives to effectively drive your team,… more
- Merck & Co. (Rahway, NJ)
- …direction of the Audit Director and the Auditor-in-Charge ("AIC"), the Specialist will:Participate in the execution of IT internal audit engagements.Support ... processes at application and infrastructure level (eg, Logical Access, Change Management, System Development Lifecycle, Information Security, IT Ops etc.)Basic… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and ... the following: + Craft business plans to independently advances change control initiatives to implement Corrective and...amounts of relevant experience for each level: + Associate Specialist - 0-2 years + Specialist -… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …is a hybrid role based out of our RTP, NC office.** **Summary:** Processes change control requests to ensure that process and documentation changes with the ... and all policies, guidelines, and standard operating procedures (SOPs) related to change control . + Processes change control request documentation… more
- Integra LifeSciences (Cordova, TN)
- …us are challenging what's possible and making headway to help improve outcomes. The Compliance Specialist - Document and Change Control plays a key role in ... success of site Quality Management and compliance activities. The Compliance Specialist - Document and Change Control is responsible for working closely with… more
- Regeneron Pharmaceuticals (Troy, NY)
- …fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ... adherence to cGMPs, internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process… more
- Regeneron Pharmaceuticals (Troy, NY)
- …a Senior Quality Compliance Specialist , Quality Assurance position on the Quality Assurance Change Control Team. This role works within the QA Change ... on the development and implementation of updates to the Change Control Partner Notification Process and associated...Senior Specialist -- 5+ years Experience in change control function strongly preferred. May substitute… more
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