- Eisai, Inc (Exton, PA)
- …into the production suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with ... R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at...close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of… more
- Eurofins (King Of Prussia, PA)
- …Testing. + GMP review of Qualification and Media Release testing. + GMP review of facility cleaning data and in-processing testing, including but not ... stocks in Europe over the past 20 years. + Water Systems + GMP review of microbiological testing of the facility and/or laboratory water purification system… more
- Merck (West Point, PA)
- …Automation, Automation Engineering, Business Process Improvements, Communication, Computer Science, Data Management, GMP Compliance, GMP Operations, ... engineer will be responsible for day-to-day operations support activities, in a GMP environment, including but not limited to the following technologies: **Key… more
- Merck (West Point, PA)
- …consultation services for regulatory reporting (eg, BPDR, DPR) + Author and/or review global standards and procedures related to biologics, vaccines, and finished ... pharmaceutical, vaccine or medical device industry experience; + Expert knowledge of GMP requirements for multiple regulatory agencies + Expert knowledge of large… more
- Teva Pharmaceuticals (West Chester, PA)
- …your main responsibilities will be scheduling and supporting microbiological laboratory testing, data review , analysis of endotoxin and bioburden samples, and ... clinical development and commercial production for biological products manufactured in a GMP production facility. **How you'll spend your day** Position Summary: *… more
- West Pharmaceutical Services (Radnor, PA)
- …integrity (CCI) assessments in compliance with Good Manufacturing Practice ( GMP ) regulations. This role involves method execution, documentation, and collaboration ... strong analytical skills, and a thorough hands-on understanding of GMP requirements. **Essential Duties and Responsibilities** + Conduct performance and… more
- Charles River Laboratories (Wayne, PA)
- …pertinent regulatory requirements and to departmental policies, practices and procedures. + Review , revise and approve ( GMP QA) SOPs, protocols/batch records, ... and understanding of regulations and quality principles. + Perform data audits to assess that records are attributable, legible,...suitability of materials and supplies for compliance with specifications ( GMP QA). + Review and approve all… more
- ManpowerGroup (Lansdale, PA)
- …high quality data . + **Experience with HPLC is required.** + ** GMP experience is required.** + Successful performance requires a sound basic knowledge of ... more senior staff member, the incumbent will carry out GMP and non- GMP testing on pharmaceutical drug... electronic notebook in compliance with regulatory requirement for data integrity, author/ review technical document. + May… more
- Merck (West Point, PA)
- …Skills:** Automated Manufacturing Systems, Business Process Improvements, Capital Projects, Data Collection Methods, Digital Manufacturing, GMP Compliance, ... include the resolution of automation problems, implementation of process control, data collection and analysis, and troubleshooting in compliance with System… more
- Pfizer (Collegeville, PA)
- …markets and applications under his/her responsibility. + Design, develop, test, and deploy data services using SAP data management tool and Syniti ADM toolset. ... audit meetings to ensure all teams involved are following appropriate SOX and GMP audit procedures and policies to maintain good compliance posture. + Provide… more
- Endo International (Horsham, PA)
- …and assist in completing process deviation investigations/unplanned events. Author, review , and approve cGMP documentation - manufacturing process and equipment ... programs. Utilize statistical control software to analyze and trend process and facility data and results. + Support the Horsham site validation program - Author/… more
- Merck (West Point, PA)
- …to motivate others to do the same **Business Expertise:** + Perform a thorough review of batch records and related GMP documentation, identifying and resolving ... timely manner and implementing corrective actions to improve the batch record execution/ review process + Work with Subject Matter Experts (SME's) to provide/track… more
- Catalent Pharma Solutions (Malvern, PA)
- …derived in support of CMTI Operations or external sample submissions. Conduct peer data review of raw data /documentation. + Provide technical training ... testing activities with clients as needed. Able to individually evaluate data and communicate information with internal and/or external stakeholders to drive… more
- Turner & Townsend (West Point, PA)
- …**Responsibilities:** + Manage Cost / Change Control, including change order review , negotiation, recommendations, and delay analysis. + Track and review ... Contractor. + Produce monthly reports for management. + Providing review reports. + Produce earned value reports. + ...cost tracking reports. + Reconcile GC actual costs with GMP / Schedule of Values. + Contract Administration (retention, T&Cs,… more
- J&J Family of Companies (Spring House, PA)
- …ensure inspection readiness at all times. **Key Responsibilities:** + Provides Quality review and guidance associated with review and approve investigations and ... corrective/preventive actions (CAPA) are implemented in a timely manner. + Review and approve controlled documents including standard operating procedures, work… more
- J&J Family of Companies (Malvern, PA)
- …with Method Development, Assay Automation, Integrations, Orchestration, Information Technology, Data Science, and Operations to increase sample testing volume while ... end-users to independently execute automated workflows + Partnering with Information Technology and Data Science teams to automate data flows to ensure data… more
- CBRE (King Of Prussia, PA)
- …Manage and improve the service logging process and asset database. Create, and review supporting documentation like service reports. + Track the performance of the ... systems to keep accurate records of all equipment-related faults. Support data -related initiatives such as contract renewal, asset replacement, etc. + Maintain… more
- Merck (West Point, PA)
- …Reliability, and Lifecycle Management). - Lead Periodic Business and Operations Review Meetings (with External Partner). . **Compliance:** Achieve compliance goals ... budgets (Expense, Capital/Prepaid, and Product Cost). Understanding of industry and economic data to make business decisions that drive value for our Company and… more
- JBS USA (Souderton, PA)
- …TECH I - 1st SHIFT - SOUDERTON, PA + Monitor SOP's, SSOP's and GMP compliance of associates, perform HACCP procedures to comply with federal regulations + Perform ... present records to them at the agency's request + Review records to ensure accuracy and be held accountable...accuracy + Aid QA supervision and management in gathering data and investigating items outside of regular technician responsibilities… more
- Staff Management | SMX (Chalfont, PA)
- …discover issues and to verify the accuracy of information, results, and data + General knowledge of ISO9000, Quality Management Systems, Good Manufacturing Practices ... & vendors to Nexus + Associate training requirements + Shift Conformance + GMP Audits, Internal Audits, GBP Audits, and Perion/Quarterly Metric Reporting + Quality… more
