cGxPServe

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited to. Discarding ob المزيد...

Responsibilities: Under (e.g. limited supervision general direction etc.) and in accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position. Lead the CIP project by interacting with internal and exte المزيد...

Responsibilities: Perform scheduled and unscheduled maintenance on GMP assets and ensure proper documentation of all work performed. Troubleshoot equipment and system failures identify root causes and implement corrective and preventive actions. Coordinate equipment relocation effort المزيد...

Responsibilities: Design History File: Ensure that the transferred process is adhering to the Device Master Record. Process Analysis and Documentation: Analyse current manufacturing processes and create detailed documentation to facilitate the transfer of medical devices to new facil المزيد...

Job Description: The chart review is critical and the candidate must have knowledge of reviewing medical records for disease process hanging blood and IV lines as well as critical care. Responsibilities: Responsible for maintaining compliance with FDA AATB international and state reg المزيد...

Job Description: Our client is strategically increasing the quantity of parts it purchases from external Supply Chain partners there is a need for Manufacturing Engineers to support the development onboarding and growth of suppliers. The goal is to ensure stable and capable manufactu المزيد...

Job Description: Supports development testing validation and documentation of biomedical software by participating as an integral team member in various phases of the System Development Life Cycle (SDLC) providing guidance on established Red Cross procedures and regulatory requirement المزيد...

Responsibilities: Lead the development validation and maintenance of statistical programs using SAS to generate tables listings and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize Adam datasets المزيد...

Responsibilities: Execute commissioning activities edit/route applicable documents for approvals and assist with qualification activities for the automated inspection machine (CAT2). Maintain document tracker execution tracker and list of open items. Adhere with project schedule for المزيد...

Job Description: This position focuses on assisting with analysing data and deriving insights from clinical and safety data sources to generate evidence and support decision making across the organization. The Associate will leverage a variety of analytics and visualization tech المزيد...

Responsibilities: Lead project management activities as below. Lead and manage product activities in whole new product development milestones from development through to launch for assigned programs. Create Integrated Project Plan using various project management tools. Manage projec المزيد...

Responsibilities: Work with Supplier functions to develop PFMEA Control plans and statistical plans (Cpks). Ensures that project and/or process control documentation is compliant with requirements and/or contract. Experience advancing Zero Defect culture utilizing advanced Quality to المزيد...

Responsibilities: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study teams. المزيد...

Job Description: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facilit المزيد...

Responsibilities: Apply subject matter expertise in mechanical design analysis and system development. Conceive and develop solutions to complex analytical pneumatic mechanical and electrical design challenges. Establish design objectives and contribute to writing specifications and المزيد...

Job Description: The Global Compound Logistics and Operations organization (GCLO) within the company manages the inventory dispersal and logistics of biological and chemical entities used by Discovery and Development scientists for all aspects of Company drug discovery. Seeking a hig المزيد...

Roles & Responsibilities: 10 to 12 years of Medical Device manufacturing experience (at least 2 to 3 years of Client experience is preferred.). Very strong experience in process development & process characterization. Good experience in process validation (IQ OQ PQ.). Good experience المزيد...

Roles & Responsibilities: Electronic Mechanical background. Demonstrated QMS experience along with documentation. Supplier Quality Management Coordination and timely interaction. V&V protocols & reports. First Article Inspection experience. Once on boarded resources will undergo exte المزيد...

Job Description: Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements process parameters and global regulatory guidelines. The role provides Operations Quality Assurance and regulatory المزيد...

Job Description: As a Quality Engineer II you will be a key contributor to the implementation maintenance and continuous improvement of the Quality Management System (QMS). You will collaborate cross-functionally to ensure compliance with regulatory requirements drive root cause inves المزيد...