- 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
- 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
- ThermoFisher Scientific (Collegeville, PA)
- …support sterile manufacturing. + Participate and oversee the preparation of GMP /GLP documents such as Standard Operating Procedures, Production Forms, batch records, ... for reporting and maintaining metrics as appropriate. Technical Writing and Review : + Support the preparation, revision, and archiving of technical documents… more
- ThermoFisher Scientific (Collegeville, PA)
- …documentation to support sterile manufacturing. + Coordinate the preparation of GMP /GLP documents such as Standard Operating Procedures, Production Forms, batch ... needs. + Report and maintain metrics as appropriate. **Technical Writing and Review :** + Prepare, revise, and archive technical documents such as area rationales,… 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
- 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
- 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
- Insight Global (Malvern, PA)
- …for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other ... drug product/drug substance samples -Perform peer reviews and approvals of laboratory data -Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and… 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
- 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
- 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
- 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