- Merck (Raleigh, NC)
- **Job Description** The Director of GMP Compliance will be a part of the Compliance Support and Remediation team within our company's Global Quality ... SMEs. **Job Function:** + serve as a subject matter expert for good manufacturing practices ( GMP ) for...authority/board of health as an inspector, investigator, product reviewer, compliance officer, or other GMP /regulatory role +… more
- Kelly Services (Durham, NC)
- …to join our team. This critical role involves ensuring the cleanliness and compliance of cleanroom, controlled environment, and GMP laboratory settings. The ... ** GMP Technician** **Location: Durham NC** **Hourly Pay Rate:...hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical… more
- ManpowerGroup (Raleigh, NC)
- …training. Strong applied and working knowledge of FDA; GMP ; GLP; compliance and NIST traceability. Expert knowledge of test equipment and capabilities ... II is expected to have a broader knowledge base of instrumentation and regulatory compliance . They will continue to train on new instrumentation areas and build an… more
- Amgen (Holly Springs, NC)
- …support of inspections. In addition, the position may entail serving as a Subject Matter Expert (SME) for GMP compliance topics in support of various aspects ... career you can be proud of. **Senior Specialist Quality Compliance ** **Live!** **What you will do** Let's do this....vital role you will be part of the Regulatory Compliance function, the Senior Specialist of Inspection Lifecycle Management… more
- Fujifilm (Holly Springs, NC)
- …investigations and optimizing laboratory systems while ensuring accurate documentation and compliance with GMP standards. Additionally, this role represents the ... The Manager, QC Virology oversees the QC Virology team, ensuring GMP -compliant laboratory operations in accordance with regulatory guidelines. This role involves… more
- Lilly (Durham, NC)
- …are determined to make life better for people around the world. The QA Compliance One-QMS Steward serves as the site lead overseeing the Quality Management System ... and to meet customer expectations and regulatory requirements. The QA Compliance One-QMS Steward is responsible for improving business processes and supporting… more
- Fujifilm (Holly Springs, NC)
- …troubleshooting complex investigations and optimizing laboratory systems. This role ensures compliance with GMP standards, maintain accurate documentation, and ... protocols, and associated reports for various deliverables while ensuring compliance with GMP guidelines. * Leads projects such as method transfers and… more
- J&J Family of Companies (Raleigh, NC)
- …Chillers, Cooling Towers, Water for Injection (WFI), compressed air, HVAC, steam, etc. ( GMP and non GMP ). **Key Responsibilities:** + Own, operate and maintain ... Utilities (Clean and Black) infrastructure assets, acting as site Subject Matter Expert (SME) for all operational, maintenance and project related scope. +… more
- Sumitomo Pharma (Morrisville, NC)
- …critical processing steps and provides real-time feedback. + Develop a Subject Matter Expert (SME) level understanding of SMPA CPC GMP manufacturing process(es) ... + Develop a suitable level understanding of Sumitomo Pharma America, Inc. + GMP manufacturing process(es) and be able to skillfully execute and troubleshoot them. +… more
- Fujifilm (Holly Springs, NC)
- …right-size approach. * Collaborates with Responsible Person(s) to facilitate timely disposition of GMP materials. * Serves as Subject Matter Expert in audit and ... Do** * Provides supervision of the QA for QC Compliance team. * Ensures allocation of adequate resources for...Sciences or Engineering and 8+ years of experience in GMP quality assurance and/or similar role OR * Master's… more
- Fujifilm (Raleigh, NC)
- …regard to biologically contaminated solid waste materials, serve as the subject matter expert for laboratory safety, be a resource to EHS teams for facility safety ... audits, and represent FDB as a biosafety subject matter expert . This role will have 7-10 direct and indirect...certifications, and related work experience. + Strong understanding of GMP principals and working within a quality centric organization… more
- Fujifilm (Raleigh, NC)
- …management systems for FUJIFILM Diosynth Biotechnologies (FDB) to ensure excellence in compliance and the ability to withstand internal and external scrutiny. The ... ensure that internal audit controls are implemented and are evaluated for compliance through audits and assessments across the FDB functions to minimize regulatory,… more
- Merck (Durham, NC)
- …laboratories using principles of our Production Systems, Lean Laboratories, and GMP requirements. **GENERAL PROFILE:** + Work cross-functionally with internal sites ... uses this knowledge in own work + Understands and applies regulatory/ compliance requirements relative to their role + Influence, motivate, and energize individuals… more
- Lilly (Durham, NC)
- …reviews, review and approval of cGMP documents, and maintaining regulatory compliance . **Key Objectives / Deliverables:** + Technical knowledge of complaint handling ... and/or quality systems + Support the QA Compliance team and site in execution of the site...+ Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Product Complaint Management procedures. +… more
- Cambrex High Point (Durham, NC)
- …interpret generated data. Ability to troubleshoot. Demonstrates strong understanding of compliance , provides input in site policy regarding compliance questions, ... ensures that client requests are within the boundaries of compliance . Responsibilities + Execute analytical methods for in-process control, release testing and… more
- Fujifilm (Holly Springs, NC)
- …excursions, and implementation of CAPAs as needed. * Serves as Subject Matter Expert (SME) in audits and inspections for the laboratory. Prepares and guides ... external training goals for self and team to ensure compliance with cGMPs and regulatory requirements. * Provides training,...in Life Sciences with 5 years of experience in GMP quality control Microbiology laboratory and/or similar role **OR**… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Skills Level II, Sr Level I (Proficient Level) Sr Level II, Principal ( Expert Level): GxP Understanding - Compliance , Change Control, Quality Oversight, ... with the building and take on automation support for GMP systems as part of the Maintenance and Engineering...Capable of adhering to Good Manufacturing Practices (GxP) - Compliance , Change Control, Quality Oversight, Validation. + After hours… more
- Sumitomo Pharma (Morrisville, NC)
- …Quality Assurance department, ensures that all activities are executed in compliance with regulatory guidelines. + Develops preventative maintenance and calibration ... definition to ensure the timely implementation of equipment improvements and compliance task (eg, change controls, investigations, and corrective and preventative… more
- Merck (Durham, NC)
- …develop and maintain global training materials, and be a subject matter expert on information systems supporting change control. **Primary activities include, but ... A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work… more
- Merck (Durham, NC)
- …weekly updates of electronic departmental metrics. + Responsible for ensuring compliance with government regulations through a demonstrated understanding of SOP's ... and general knowledge of company policies/guidelines, safety/environmental regulations, and GMP 's. + Attend Production Tier 1 and EN Huddle meetings and escalate… more