cGxPServe

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: 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...

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: 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...

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: 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...

Position Summary: We are seeking a highly skilled and detailoriented Senior Quality Engineer to lead quality initiatives and ensure compliance with applicable standards in a dynamic manufacturing environment. This role requires a deep understanding of quality management systems conti More...

Responsibilities: Fidelity Talent Source is your destination for discovering your next temporary role at Fidelity Investments. We are currently sourcing for a Full Stack Engineer in Merrimack NH! We are seeking a highly skilled and experienced software engineer to join our dynamic te More...

Responsibilities: Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals. Align CMC regulatory plan 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: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrut. Fill and operate shelf carton erector and clear minor jam. Responsible for quality of product including but not limited to. Discarding obv More...

Responsibilities: Responding to Benefit related questions may need to search multiple systems to research answers. Delivers accurate and timely welfare benefits administrative support to internal/external stakeholders including employees managers HR community and thirdparty vendors 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...