- 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
- Eurofins (Lancaster, PA)
- …data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations. + Review simple and complex routine and non-routine ... laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations + Review simple and complex routine and non-routine data (for… more
- Eurofins (Lancaster, PA)
- …confidence + Demonstrate motivation and take initiative + Follow through on assignments + Process/ review data , generate/ review reports, and evaluate data ... client received quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP...technique, and high degree of accuracy and precision + Perform/ review preparations of reagents, samples, and standards according to… more
- Eurofins (Lancaster, PA)
- …confidence + Demonstrate motivation and take initiative + Follow through on assignments + Process/ review data , generate/ review reports, and evaluate data ... client received quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP...technique, and high degree of accuracy and precision + Perform/ review preparations of reagents, samples, and standards according to… more
- Eurofins (Lancaster, PA)
- … data as required, as well as understand data patterns + Identify and report data patterns found during data review + Document data following SOPs ... entire network of Eurofins companies. Essential Duties and Responsibilities: + Applies GMP /GLP in all areas of responsibility, as appropriate + Demonstrates and… more
- Eurofins (Lancaster, PA)
- … data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations + Review simple and complex routine and non-routine ... This individual will work in a duel analyst and data reviewer role. The Scientist will be...analytical procedures; ensure all work is performed according to GLP/ GMP requirements and apply GLP/ GMP in all… 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
- Eurofins (Lancaster, PA)
- …other written material. Technical Writer Essential Duties and Responsibilities: + Applies GMP /GLP in all areas of responsibility, as appropriate + Applies the ... and any other documents + With support, Interact with Group Leaders, Data Reviewers and Scientists to gather the information necessary to the generation… 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
- Black & Veatch (Wilmington, DE)
- …reviews, requests for information, correspondence, change requests, pay application processing, GMP review , direction/supervision of inspection staff, and ... cost estimators, GIS, designers, and other engineers and construction professionals). . Review and analyze engineering data and reports. . Lead construction… 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