cGxPServe

Roles & Responsibilities: 3 years of experience in the Pharma and/or Consumer Health industry. Strong understanding of regulatory requirements and industry standards. Previous experience in Document Management systems (e.g. Veeva Documentum Enovia) to create store and manage document More...

Responsibilities: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for More...

Job Description: We are seeking a highly motivated Research Associate to join our team on a contract basis to support key cellular and biochemical studies. The contractor will be responsible for the isolation and characterization of primary human (and occasionally monkey) blood cells More...

Roles & Responsibilities: Experience with and expertise in designing and configuring workflows and implementing ARAVO thirdparty risk/performance management product solution. Implementing the workflowlevel system configuration and unit testing including enhancement and future de More...

Job Description: The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables assemble and autoclave assemblies for More...

Responsibilities: We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. This role offers the flexibility of being fully remote or hybrid catering to your worklife balance needs. work hours: 8am to 4pm. Coordinate and p More...

Job Description: Develops and improves manufacturing processes by studying product and manufacturing methods. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design fabrication assembly tooling and materials; conferring w More...

Responsibilities: Support activities within MSATUS regarding technical documentation SOPs and internal systems. Development of technical positions regarding packaging and Pharma process equipment material and component performance and Regulatory compliance for Client packaging proces More...

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA 21 CFR 820 ISO 13485 and other rele More...

Job Description: The Facilities Suite & Elastomer Maintenance Mechanic Level III provides support to the Engineering Services group by operating and performing daily checks on Direct and Indirect Maintenance equipment/systems and assists higher level mechanics with repairs in complia More...

Job Summary: We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy integrity and quality of clinical trial data while collaborating More...

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. Comp More...

Responsibilities: Develop and execute commissioning protocols (FAT SAT IQ OQ and PQ) for equipment systems and facilities. Perform system startup debugging and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specif More...

Responsibilities: Demonstrated practical understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated satisfactory ability to apply SAS programming knowledge and work independently to solve problems related to nonroutine situation More...

Job description: Quantitative Translational & ADME Sciences Department has an open position for a Scientist II position in North Chicago IL. The successful candidate will be responsible for nonregulated quantitative LCMS/MS bioanalysis of small molecules from in vivo and in vitro samp More...

Responsibilities: Attending multidisciplinary team meetings representing the programming function. Create or review and approve programming plans at study and project level. Provide input on key studyrelated documents produced by other functions (e.g. CRFs Data Management Plan SAPs More...

Responsibilities: Perform nonconformance (Client) investigations within the Track Wise 8 Management System. Execute implementation of CAPAs associated with Client investigations. Maintains a high level of expertise in current regulatory requirements and serve as a plant resource for More...

Responsibilities: Performs inspections and sets quality assurance testing models for analysis of raw materials materials in process and finished products. Requires a bachelors degree and 02 years of experience in the field or in a related area. Has knowledge of commonly used concept More...

Responsibilities: Lead Data Management Activities Perform Training and Client Relationship Management. Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan log and report issues and follow up on their resolutions. Is the primary contact person f More...

Job Description: Provide Quality Assurance (QA) oversight for Computer Systems Validation (CSV) activities supporting the LabVantage 8.7 enhancement project and other digital initiatives. This role is focused on reviewing and approving validation documentation not authoring it though More...