- 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
- Fujifilm (Warminster, PA)
- …+ Support scale-up of formulation and lyophilization processes for pilot and GMP manufacturing. + Present formulation data to cross-functional teams and ... + Able to troubleshoot equipment and experimental problems independently. + Perform advanced data analysis, use of statistical software and generate summary data … 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
- The Estee Lauder Companies (Bristol, PA)
- …pH meter, pull force, seal burst, and other relevant equipment) . Ability to review SOP's, GMP reports, batch records and investigations Proficiency in Microsoft ... and providing training and coaching to Quality and Operations on SOP, GMP , and root cause analysis. Personnel Management & Training ⁃ Manage/coordinate the… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …phase I/II clinical trials in HIV and cancer under Good Manufacturing Practice ( GMP ) guidance and Good Laboratory Practice (GLP) compliance. The cGMP Operations and ... templates and cGMP culture lengths as appropriate. + Consistently review the upcoming cGMP production and clinical infusion product...+ Serve as backup for billing for CVPF services. Data tracking for CVPF and HIC + Ensure up… 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
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... demands and site objectives. Additionally, material planning, procurement and inventory review are conducted to maintain optimal inventory while meeting production… 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
- Exelon (Philadelphia, PA)
- …distribution assets, including contracting on an EPC (traditional and progressive) / GMP model Under minimal supervision, plans, conducts and supervises complex legal ... business risks and liability of strategic initiatives and advises clients accordingly. Review and draft legal documents and work closely and cooperatively with… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …preferably with Microsoft Office and JDE + Prefer experience in Documentation including document review , data review , and Standard Operating Procedures etc + ... global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network.… more
- University of Pennsylvania (Philadelphia, PA)
- …work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human ... human clinical trials in immunotherapies. Main duties include: + Review of manufacturing batch records and product release documentation...science preferred + 1-3 years of experience in a GLP/GCP/ GMP setting, or equivalent, with >1 year of direct… 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
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... report budget variances. Assist and generate billing of invoices, review and maintain work file process. Work with Contracts...IOR + Collaborating with other departments to ensure financial data is accurate, complete, and in compliance with GAAP… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... requests, quality issue resolution, CAPAs, process control, validations, and data integrity assessments + Understands and partners with Quality/Production/Project… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... specific assigned production room operation. + Responsible for entering data accurately in batch records and logbooks. + Must... accurately in batch records and logbooks. + Must review completed manufacturing and packaging batch records in a… more