- Integra LifeSciences (Braintree, MA)
- …quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... and checklists. + Assist as needed in test method validation , investigation studies or other product development studies. +...studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Bausch Health (Bothell, WA)
- …with the Company, applicable standards (eg IEC14971, IEC60601, & ISO13485), FDA and other requirements, identifying and developing test methods and individual ... cases and write verification test protocols for software and hardware verification/ validation that utilize manual and automated test methods. Design and/or develop… more
- Integra LifeSciences (Braintree, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Unither Pharmaceuticals (Rochester, NY)
- …Maintains and updates training records in a timely manner. Methods & Validation * Supports method development/ validation and method transfer activities. Problems ... assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA , DEA, USP, EP, and OSHA regulations. Trainees Demonstrate the Ability to… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- J&J Family of Companies (Raritan, NJ)
- …therapy industries + Basic IT Knowledge + Knowledge or experience with CSV ( Computer System Validation ). + Hands-on experience with HVAC controls programming and ... and implement corrective actions, with experience in system qualification and validation . + Manage change control processes for system modifications or updates,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …role will also support clinical/biomarker assay development and validation . For more information on CMC, click here ... and leadership for Takeda clinical and biomarker assay development and validation . + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system… more
- Astellas Pharma (Sanford, NC)
- …the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and ... includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer… more
- Epredia (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and...clients to carry out the work assigned. + Advanced computer skills, Windows Suite, CAD, Label design. + Advanced… more