cGxPServe

Job Description: Protocol Review & Compliance: Study and assess Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance. Process Audits & Documentation: Conduct thorough audits of 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: Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Responsible for new product setup quality project management and regulatory compliance of serum produ More...

Responsibilities: Represent Data Management in study team meetings providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensure the quality and timeliness of data from service 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: Process Validation and IQ-OQ-PQ Experience in medical parts manufacturing experience is the key with process validation expertise around 8 to 10 yrs experience. Protocol Review & Compliance: Study and assess Installation Qualification (IQ) Operational Qualificat More...

Responsibilities: Recipe Authoring using Syncade MES. Execute test scripts (design execution simulation wet testing). Own change requests and complete change request tasks to support project completion. Perform change request assessments. Deviations / Root Cause Analysis (RCAs). Assi More...

Job Description: The primary need is help with execution for equipment and process validation protocols. Role will work with the San Diego team and Ireland teams. Ability to manage different time zones and teams is very important. The ideal candidate will have less than 10 years of e More...

Job Description: Working with the Biometrics staff the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy. The candidate programs SDTM/ADaM/TL More...

Job Description: The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Contractor will partner with Business Owners Technical Owne More...

Responsibilities: Participate in Suppliers and contract manufacturers performance scorecards as required. Coordination and execution of QMS audits (Internal and Vendor) as required. Act as Quality representation for product innovation processes as directed by the Quality Director. Co 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...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials regulatory agency meetings orphan designations paediatric planning and accelerated procedures ensuring timely preparation of well organized quali More...

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 More...

Job Description: We are seeking a Packaging Operator to execute packaging and labeling processes per Batch Record requirements in accordance with cGMP guidelines. This role includes documentation cleaning equipment setup and collaboration across departments to maintain production comp More...

Responsibilities: Develop and maintain SAS programs to import clean and validate clinical trial data. Use R for data manipulation analysis and visualization. Perform statistical analyses in accordance with study protocols and analysis plans. Generate tables listings and figures (TLFs More...

Responsibilities: Daily on-site Construction Management for multiple projects monitor construction contractors for (each project) daily monitoring for PPE and safety compliance assisting with issuing safety permits and handling day to day construction questions. Escalating concer More...

Responsibilities: Lead quality engineering activities for new hardware/software medical device development including design control and risk management. Develop and maintain Risk Management File (RMF) dFMEA pFMEA hazards analysis and risk reports. Review/approve Design History File ( 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...