cGxPServe

Roles and Responsibilities: Prepare test protocols and completion reports. Conduct testing in the lab understand flow of events and needby timelines coordinate and communicate with all parties and mitigate any problems that arise. Perform test method and fixture updates including tes More...

Job description: This position of Validation Specialist III in the Manufacturing Science Technology and Analytics (MSAT) function of M&SV is to support manufacturing toward industrial excellence to guarantee the accuracy conformity and competitiveness of the processes and techniques u More...

Responsibilities: The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices. This role involves ensuring compliance with global regulations preparing and managing regulatory submissions and ac More...

Responsibilities: Serve as the main contact for servicerelated inquiries from recruitment managers employees and other HR team members. Ensure the complete resolution of HR requests including tracking and tracing. Offer outstanding customer service by promptly resolving queries and i 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 e More...

Roles & Responsibilities: Must have deep experience in Lab Vantage LIMS experience including ELN and the Stability Module. At least 5 years of experience. Experience in process of transitioning to Lab Vantage Stability LIMS. Experience in implementing ELN.

Responsibilities: Candidate must be able to answer questions in the STAR format (Situation Task Action Result). If they cannot formulate a response this way please coach or whittle down the resume. Note answers should pull from multiple projects and not the same one over and over. C More...

Responsibilities: We are seeking a highly skilled Statistical Programmer to generate and produce programming deliverables such as datasets tables figures and listings for study reports and integrated summaries using statistical analysis systems (i.e. SAS . The ideal candidate will s More...

Job Description: The Project Manager Combination Products Development is accountable for leading the cross functional team (Engineering Quality Supply Chain Marketing Operations Human Factors and External Partners) in the of a portfolio of projects focused on the delivery system cons More...

Job description: The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes follow written procedures (SOPs) monitor equipment and processes perform basic laboratory tasks inc More...

Responsibilities: Serve as the main contact for servicerelated inquiries from recruitment managers employees and other HR team members. Ensure the complete resolution of HR requests including tracking and tracing. Offer outstanding customer service by promptly resolving queries and i More...

Responsibilities: Regulatory Affairs Specialist* This position assists the Director of Quality Operations (DQO) in maintaining an effective Quality Operations and Regulatory Program which consistently delivers high quality EZIP products on time. Handles regulatory submissions CAPAs c More...

Job description: The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes follow written procedures (SOPs) monitor equipment and processes perform basic laboratory tasks inc More...

Responsibilities: Proven leadership in testing/validation for medium to large system implementations ensuring GxP compliance and quality delivery. Extensive experience with Waterfall Iterative and Agile methodologies guiding teams to successful project outcomes. Proficient in Microso More...

Responsibilities: Involved in the programming activities on multiple projects/ studies across various therapeutic areas both internally and externally by CROs. Creates and reviews annotated CRF to SDTM datasets. Provides support in balancing conflicting priorities promoting communica More...

Responsibilities: Leads a large clinical study or a series of related studies with minimal guidance. Represents Data Management at study management team meetings. Provides mentoring and training to lowerlevel Data Management staff assigned to his/her studies Manage and monitor the pr More...

Responsibilities: Supplier Engineer responsible for managing overall supplier manufacturing operation issue across supplier base ensuring process controls are established and ensure throughout the suppliers entire manufacturing process. Involve in Supplier Issue Resolution. Work on C More...

Job Summary: We are seeking a detailoriented and technically skilled Veeva QMS Support Specialist to provide enduser support configuration assistance and continuous improvement for our Veeva Quality Management System (QMS). This role serves as a bridge between Quality IT and end users More...

Job Summary: We are seeking a skilled and motivated .NET Developer to join our dynamic team. The ideal candidate will have a strong background in software development with experience in designing developing and maintaining applications using the .NET. This role requires a professional More...

Job Description: The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes follow written procedures (SOPs) monitor equipment and processes perform basic laboratory tasks inc More...