- 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
- 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
- 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 (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
- 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
- Merck (Wilson, NC)
- …including reviewing and approving IT documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety. + Develops solutions for general IT ... of significant IT related issues and maintenance of IT systems in compliance with cGMPs, SLC, safety, and environmental regulations. Provides coaching and guidance… 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 (Wilson, NC)
- …activities, responsibilities, and competencies include but are not limited to the following: ** Compliance :** + Act as site subject matter expert for MDCP related ... site's MDCP program. Primary responsibilities include ensuring that high standards for MDCP compliance are maintained at the site and that key projects related to… more
- Eurofins (Raleigh, NC)
- …Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC ... understanding of regulatory requirements and a passion for helping clients maintain compliance and ensure the integrity of their operations. Regional Sales Manager… more
- CDM Smith (Raleigh, NC)
- …delivery managers, and vendors -Assist with the coordination and development of GMP Guaranteed Maximum Price) documents -Prepare, monitor and manage project budgets ... -Promote design build best practices, including constructability reviews, schedule compliance , and quantity management -Be active in professional societies in… more
- ManpowerGroup (Raleigh, NC)
- …and interpret P&IDs and identify boundaries + Working knowledge of and ability to apply GMP , GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as ... millions of people across a wide range of industries and skills. Our expert family of brands -_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _-_… more
- Merck (Wilson, NC)
- …are not limited to, the following:** + Act as a global Subject Matter Expert (SME) for primary packaging and device components; this expertise must span the ... 5 years in pharmaceutical manufacturing or technical support roles related to GMP manufacturing of Large Molecule and Sterile Small Molecule products + Strong… more