cGxPServe

Responsibilities: Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Work on non-conforming (NC) reports (Initiate Analysis Investigation Review and close). Work with third party supplier to resolve issue المزيد...

Job Description: The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Ma المزيد...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project المزيد...

Responsibilities: Responsible for the design development and implementation of standards methods and procedures for inspecting testing and evaluating the precision and accuracy of company products in compliance with contractual and regulatory requirements. Performs analysis on re المزيد...

Responsibilities: Review protocols and comply with study-specific activities that impact telemetry areas of responsibility. Communicates in an appropriate and professional manner with study subjects and unit personnel. Maintain accurate and complete source data. Perform study protoco المزيد...

Responsibilities: Medical Device Quality Inspector: Responsible for assuring that materials activities processes and specified conditions related to the daily device manufacturing processing and packaging meet current GMP standards and comply with applicable procedures and standard المزيد...

Responsibilities: Serve as the principal programming lead across multiple studies or a clinical program ensuring timely accurate and regulatory-compliant deliverables. Lead or contribute to the development validation and documentation of SDTM ADaM and TFLs in support of clinical stud المزيد...

Responsibilities: Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development market access and commercial use cases for our life sciences partners. Independently translate analytic specificat المزيد...

Responsibilities: Collect enter and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the development of case report forms (CRFs) and data manageme المزيد...

Job Description: This position is responsible for adhering to documented procedures and work instructions associated with the proper decontamination of product returned for servicing as defined in the BDI/Dymax Quality Management System. Responsibilities: Conducts decontamination of المزيد...

Responsibilities: Contribute to continuous improvements in overall product cost and quality. Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. Collaborate with Quality Engineering to provide manufacturing supp المزيد...

Job Description: The Medical Project Office within Medical Program Management is charged with consolidating and standardizing repeatable activities to ensure high quality consistency accuracy and efficiency. The Manager Medical Ad Board & Symposium Execution is responsible for providi المزيد...

Job Description: We are seeking a highly skilled Equipment and Automation Controls Engineer to join our team. This role involves designing implementing installing analyzing and/or optimizing manufacturing processes procedures equipment and programming. The ideal candidate will also ha المزيد...

Responsibilities: Primary - Review and process first part approvals for Customer New Product Development (NPD) initiatives including development review and submission of all required supporting documentation. Work with Customer facilities as required to achieve acceptable outputs fro المزيد...

Responsibilities: Lead the development validation and documentation of CDISC-compliant SDTM and Adam datasets for CNS clinical trials ensuring traceability from raw data through analysis outputs. Program and QC tables listings and figures (TLFs) for interim and final clinical study r المزيد...

Job Description: Performs a variety of chemical analyses and GMP review in accordance with cGMP GLP DEA and company policies and procedures. Responsibilities: Perform routine testing (dissolution assay/degradant content uniformity and ID) of drug products in a cGMP laboratory. Comple المزيد...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an المزيد...

Responsibilities: Develop implement and maintain quality systems and procedures in compliance with FDA EMA and cGMP regulations. Support deviation investigations CAPAs and change control activities. Review and approve manufacturing and quality documentation including SOPs batch recor المزيد...

Job Description: The Hillsboro Innovative Therapies (HIT) team at the client site is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies cell therapi المزيد...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al المزيد...