- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports. Support the change management process for validated systems where ... performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success… more
- Aequor (Austin, TX)
- Remote - EST or CST time zone preferred. MANAGER IS OPENING CAP, PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: ... the largest project? (5) During the interview with hiring manager , you will be asked to walk through the...master services agreement. How did you use Ariba to process the final Master Agreement for review and obtain… more
- Aequor (Thousand Oaks, CA)
- …in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate ... instruments and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines and improves quality. Coaches and mentors' colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed ... This position will work cross-functionally to execute the outsourcing process . Responsible for appropriate utilization and application of advanced negotiation… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT to implement and maintain Eisai's global ... eTMF system related activities Ensure eTMF system and associated process align with ICH-GCP, regulatory and Eisai SOPs O...and related TMF setup and maintenance processes, eTMF user support and training. Engagement with Eisai functional and CRO… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role ... OverviewThe Warehouse Operations Manager will work within Technical Operations and be responsible...individual will partner Technical Operations with other functions to support the production and distribution of cell therapy products… more
- Aequor (Pearl River, LA)
- …change controls, protocols and deviations. 2. Work closely with manufacturing, validation and quality team to ensure accuracy and completeness of documentation ... documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.… more
- Merck & Co. (Durham, NC)
- …Automation, Technology, and other groups as required.-Responsible for supporting:- Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns). ... and collaboration skills responsible for leads peers in supporting the manufacturing process . Individual will possess the ability to lead a team, train others… more
- Merck & Co. (Durham, NC)
- … Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)- Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems ... and collaboration skills responsible for leads peers in supporting the manufacturing process . Individual will possess the ability to lead a team, train others… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for reviewing and approving, of standard operating procedures (SOPs), validation / qualification/ method.Key Responsibilities Be responsible for providing quality ... with Janssen policies, standards, procedures, and Global cGMP.Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP… more
- Merck & Co. (Durham, NC)
- …Direct support of regulatory inspections and audits, as requested Direct support of validation activities and all other associated Quality functions Other ... with Production, Technology, and Quality Assurance as required to support vaccine manufacturing.Primary Responsibilities General Profile Ability to work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards ... individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the...on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product manufacturing per inspection plan and record results to complete receipt process . Reviews inspection documentation (C of A or other Material Certifications) ... and under the appropriate storage conditions.Make appropriate quality decisions in support of warehouse activities.Ensure that cycle counts are accurate and… more
- Catalent Pharma Solutions (Bloomington, IN)
- …quality standards and requirements of company policies and FDA regulations. **The Process Validation Manager 's responsibilities include managing multiple ... managing protocol and report development, execution and approval associated with process validation , reviewing and approving documentation, evaluate and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Oversight department at Regeneron is adding to their team! The ** Manager , Process Validation Oversight** leads a department responsible for the ... qualification of the equipment, systems, and processes validation for our CMO and partner groups in accordance with regulatory requirements and support , follow… more
- Reynolds American (Winston Salem, NC)
- Validation Compliance Manager ( Process Validation ) **Reynolds American is evolving at pace into a global multi-category business. We are on a mission to ... journey!** **REYNOLDS AMERICAN has an exciting opportunity for a Validations Compliance Manager ** **in Winston Salem, NC** The Validation Compliance Managers… more
- PCI Pharma Services (Philadelphia, PA)
- …to pioneer and shape the future of PCI. Job Title: ** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities** Department/Group: ... Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and...strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Manager , QA Validation Department: QA Validation Location: Monroe, NC START YOUR APPLICATION ... as a leading integrated research-based pharmaceutical company. POSITION SUMMARY : The Manager , QA Validation is responsible for providing leadership and… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Manager , Sr. Validation Engineer I supports the successful implementation of ... + Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of… more
- ThermoFisher Scientific (High Point, NC)
- …NC (youtube.com) (https://www.youtube.com/watch?v=B1kzDFF39XU) **How will you make an impact?** The Manager of Validation will be responsible for leading the ... about supporting robust processes, product life cycle and managing site validation activities. This includes supporting process development activities and… more
