- Merck (Trenton, NJ)
- **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
- Endo International (Horsham, PA)
- …Develop and implement solutions to validation related discrepancies and deviations + Ensure compliance to data integrity requirements in a GMP environment + ... support for issue resolution. Additionally, this role would be the Subject Matter Expert for Data Integrity for the Quality Control department. The role is… more
- Fujifilm (Trenton, NJ)
- …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
- Actalent (Sellersville, PA)
- …System (QMS) is maintained to applicable Good Manufacturing Practice ( GMP ) requirements. Responsibilities + Identify areas of continuous improvement within ... other departments in areas of the PPS QMS and GMP requirements. + Support the Quality teams regarding projects...+ Support the teams as the system Subject Matter Expert (SME) and/or administrator for creating CAPAs, change controls,… more
- Merck (West Point, PA)
- …Operations, and Regulatory groups to meet targeted supply and compliance initiatives. Polysaccharide Vaccines includes fermentation processing, vaccine purification, ... be responsible for providing Deviation Management support, and becoming a technical expert to support the manufacture of these products. **Key Responsibilities** +… more
- Kelly Services (West Point, PA)
- …in support of sampling and material transfer. Maintain training and compliance with site safety and quality requirements. Selected Responsibilities: + Print, ... for clinical product labels. + Process labeling/packaging batch paperwork according to GMP /GDP. + Verify before use that equipment calibration date has not been… more
- Kelly Services (West Point, PA)
- …tasks related to clinical label printing production. Maintain training and compliance with site safety and quality requirements. Selected Responsibilities: * ... for clinical product labels. * Process labeling/packaging batch paperwork according to GMP /GDP. * Verifies before use that equipment calibration date has not been… more
- BeiGene (Hopewell, NJ)
- …Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists associates with deviation management and ... as ensuring the departmental performance against goals. + Site expert on ERP software such as SAP + Reviews...all Quality Assurance floor activities and systems to ensure compliance with FDA/EU regulation, covering cGMP for commercial medicinal… more
- WuXi AppTec (Philadelphia, PA)
- …concepts + Oversees and monitors overall performance of aseptic technique ensuring compliance with standards + Has performed aseptic technique, is able to identify ... feedback for facility fit + Helps with application of GMP concepts and is able to recommend and identify...proficiency and able to act as an subject matter expert (SME) and/or Super user on multiple systems +… more
- BeiGene (Hopewell, NJ)
- …Batch Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists shop floor Mfg. associates with ... monitoring all Quality Assurance shop floor and batch systems to ensure compliance with FDA/EU regulation, covering cGMP for commercial medicinal products and… more
- Eurofins (Philadelphia, PA)
- …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
- WuXi AppTec (Philadelphia, PA)
- …protocols and other technical transfer documents * Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the ... proficiency and able to act as an subject matter expert (SME) and/or Super user on a system *...data and recommends path for forward processing * Follows compliance and regulatory requirements and current Good Manufacturing Practices… more
- WuXi AppTec (Philadelphia, PA)
- …transfer activities * Provides feedback for facility fit * Helps with application of GMP concepts and is able to recommend and identify improvements as the process ... proficiency and able to act as an subject matter expert (SME) on a system * Understands the concept...data and recommends path for forward processing * Follows compliance and regulatory requirements and current Good Manufacturing Practices… more
- CSL Behring (King Of Prussia, PA)
- …in Study Execution Teams, Clinical Development Teams and Product Development Expert Team/Chemistry, Manufacturing, and Controls Team. + Determine labeling and ... study assumptions, creates Purchase Orders, reviews, and approves invoices. + Ensure compliance of all clinical study activities with SOPs and regulations for… more
- Kelly Services (Cherry Hill, NJ)
- …quality. **Key Responsibilities:** + Conduct all required product and batch inspections, ensuring compliance with GMP and GLP standards. + Perform analytical and ... and quality of our products. This position is responsible for maintaining compliance with customer and regulatory standards through effective application of quality… more
- Merck (West Point, PA)
- …clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional projects, etc.) + Demonstrates high capability to ... in project / portfolio management. + Knowledge of Good Manufacturing Practices ( GMP ) and Good Clinical Practices (GCP) is highly desirable. **Preferred Experience… more
- Merck (West Point, PA)
- …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