- 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
- Meta (Trenton, NJ)
- …(DEC) organization to direct contracting across the full E2E project lifecycle of data center campuses in North America. There has never been a more exciting ... team of industry leaders! **Required Skills:** Lead Contracts Manager - Data Center Design, Engineering & Construction Responsibilities: 1. Direct the overall… 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
- 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
- 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)
- …and deviations. + Responsible for assay monitoring ensuring method performance data are presented, discussed and actions developed at analytical working group ... Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports. + Escalation of key assay challenges… more
- BeOne Medicines (Pennington, NJ)
- …regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks ... direct reports, to ensure compliance with business procedures and GMP 's + Ensuring appropriate investigation of discrepancies, errors, complaints, failures,… 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
- 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
- Eurofins (Horsham, PA)
- …standards, and will play a vital role in maintaining compliance with GMP /ISO standards. Quality Specialist, Culture Media Responsibilities include, but are not ... pre-determined product specifications outlined in approved production worksheets + Review production worksheets and material specifications for completion, accuracy,… 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
- Cardinal Health (Trenton, NJ)
- …of the Approved Supplier List. + Risk Assessments: Gathers and/or verifies data obtained from various regulatory and internal sources to determine Supplier risk ... profiles. + Audit Program: Develop annual audit schedules, review audit reports, ensure adequacy of supplier responses to...+ 4-8 years of experience in a regulated pharmaceutical GMP environment, preferably manufacturing. + BA, BS or equivalent… 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. ... for assessing capability gaps through analysis of business performance data , designing training programs, delivering efficient and effective training, and… 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
- 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. ... analysis, including margin analysis and profitability assessments for management + Review and update cost accounting methods, processes, and procedures to improve… more