cGxPServe

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 lower-level Data Management staff assigned to his/her studies Manage and monitor the p المزيد...

Job Description: The client is seeking a hands-on Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs. This role focuses on ensuring the quality and integrity of new and existing products i المزيد...

Responsibilities: This individual will play a critical role in supporting the start up of 4 manufacturing lines ensuring successful equipment transfers and validation processes. This individual will provide engineering leadership manage validation activities and develop action plans المزيد...

Responsibilities: Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy chromatography protein analyzers المزيد...

Job Description: Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activites. Also participate in quality testing for customer in-process final prod المزيد...

Responsibilities: Lead the preparation review and submission of CMC sections of regulatory filings (e.g. INDs NDAs BLAs MAAs variations renewals) to global health authorities ensuring accuracy completeness and compliance with applicable regulations and guidelines. Provide regula المزيد...

Note: Entry level assembly position. Must be able to follow procedures to assemble electronics. Previous experience in assembly is helpful. Use of hand tools (screwdriver). Follow written directions. Roles & Responsibilities: Will be responsible to work in a team atmosphere on produc المزيد...

Job Description: The position of Warehouse Team Member performs activities related to the receipt shipment movement manufacture or control of raw materials product recyclable materials and waste. Operates equipment/machinery when necessary. Responsibilities: Performs activities rel المزيد...

Responsibilities: Responsible for representing the sites quality initiatives and compliance objectives in the development of methods procedures validations and quality planning for the facility. Requirements: Bachelors Degree required preferably in Science Chemistry or Biology. Min المزيد...

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 المزيد...

Responsibilities: Responsible for Implementation Plan Impact Assessment Test Plan/ Results Defects and RTM Prior experience in using tools like ALM DMS and JIRA Good to have experience in implementing US-DSCSA. Single point of contact for Geo and functional specific scope of service المزيد...

JOB DESCRIPTION: The Payroll Specialist will play a crucial role in ensuring accurate and timely payroll processing for our employees across the US and Canada. This position requires a detail-oriented individual with strong analytical skills and the ability to handle sensitive informa المزيد...

Job Description: The client is seeking a hands-on Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs. This role focuses on ensuring the quality and integrity of new and existing produc المزيد...

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 المزيد...

Responsibilities: This section focuses on the main purpose of the job in one to four sentences. This position is responsible for complaint handling will triage incoming complaints for the assigned team and will process all levels of complaints without supervision. This section co المزيد...

Position Summary: Client is seeking three (3) technically proficient LabVantage LIMS Specialists with 3 5 years of experience to support ongoing system operations enhancements and upgrades. This role focuses exclusively on technical expertise within LabVantage and will operate on a المزيد...

Responsibilities: Manage supplier manufacturing and operational issues across the supplier base. Ensure process controls are in place and maintained throughout the suppliers manufacturing process. Lead supplier issue resolution and implement corrective actions (CAPA 8D). Collaborate المزيد...

Job Description: Quality Engineer with validation change control technical writing and process mapping experience. Ideal candidate around Oregon OH but also open to Knoxville TN or Denver CO. Experience with Medical device or Pharma would be a plus. Responsibilities: Responsible fo المزيد...

Job Description: Provide design assurance support for new product development and on market medical devices. This role will be responsible for facilitating the application of design controls while supporting product development manufacturing related design changes maintaining regulat المزيد...

Job Description: You will be responsible for supporting the overall technical direction and work for novel Acute Therapies products. Based on your technical skills you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle ma المزيد...