cGxPServe

Responsibilities: Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations. Maintain and support the Quality Management System (QMS) for distribution operations. Prepare and maintain Quality Agreements. Handle deviations CAPAs change controls More...

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required) and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contribu More...

Responsibilities: Conduct independent model validation and provide a comprehensive effective challenge of models by partnering with model owners and developers following company policies regulatory requirements and industry best practices. Develop and maintain effective working relat More...

Responsibilities: Creation of SAS programs to Develop or Validate SDTM/Adam/TLFs. Provide oversight for CRO SDTM/Adam/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level. Generate and/or review of SDTM mapping specifications annotated CRFs Ad More...

Job Description: The Lead HR Generalist reporting to the Sr. HR Manager is responsible for delivering the end-to-end Human Resources agenda for assigned departments and functions at the site. The role involves implementing and maintaining procedures and programs for site employees in More...

Responsibilities: Perform routine analytical testing to support quality control testing of pharmaceutical products. Some data interpretation required. Coordinate testing of samples and input data into computer application. Should have good laboratory skills preferably in pharma/biote More...

Job Description: You will support multiple NV product lines at the Toledo site by leading and/or supporting process and cost optimization initiatives. The role focuses on equipment/process validation lean manufacturing and driving cross-functional project execution in a regulated med More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Responsibilities: Analytical chemist responsible for commercial and pipeline small molecule development within Product Development Science & Technology Operations. Perform routine analytical chemistry tests competently and independently to generate reliable and consistent results. Le More...

Job description: The Laboratory Coordinator will develop and administer various laboratory equipment support functions throughout Client R&D sites. This position involves serving as liaison among internal Client personnel as well as external organizations to aid in equipment selection More...

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including b More...

Responsibilities: Provide engineering guidance to R&D partners. Utilize experience and knowledge to drive Safety Quality and Efficiency throughout the process and packaging development. Specify processing methods and equipment requirements for new products. Specify packaging methods More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s More...

Job Description: CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. This person will work More...

Job Description: The Associate QC Scientist performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials in-process product final Bulk product stability and/or validation. Analyzes test data and evaluates results. Writ More...

Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages IND/CTA NDA and MAA regulatory filings. Prepare and review CMC submission documents registration dossiers health authority More...

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including b More...

Job Description: Our client is seeking a Quality Engineer with experience in the medical device industry to support quality assurance and regulatory compliance efforts across product development and manufacturing. The ideal candidate will have a strong understanding of ISO 13485 FDA 2 More...

Responsibilities: Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. Lead database build activities including leading cross-functional review of eCRF content review of edit check specifications and perform user acceptance test More...

Responsibilities: Review protocols and comply with study-specific activities. Communicates in an appropriate and professional manner with study subjects and unit personnel. Maintain accurate and complete source data. Perform study protocol related activities i.e. phlebotomy sample pr More...