- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in the implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud technologies and ... is seeking an experienced and dynamic Senior Manager, IS Quality to build and lead our IS Quality...ensure compliance with GxP regulations and industry best practices.System Validation Oversight: Oversee all aspects of computerized system … more
- AmplifyBio (West Jefferson, OH)
- …quality . Achieves high quality results by collaborating with Study Management, Quality IT , Data Operation, Quality Assurance, and appropriate project ... knowledge of performance and operations management. Experience with relevant regulations and quality standards including US FDA /EPA GLPs. Solid computer skills,… more
- Novo Nordisk Inc. (Durham, NC)
- …system assessments & testing of operating systems, software, & hardware Perform automation/ IT validation activities in accordance with Novo Nordisk procedures & ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...understand the QC lab computer systems Adhere to the automation/ IT standards & implement the necessary changes to the… more
- DivIHN Integration Inc (Atlanta, GA)
- …Review/revise Validation Policy and SOPs as directed. File validation documentation within following Quality Assurance Library guidelines. COMPETENCIES: ... Customer Service Focused; Information Technology background, experience within a Quality /Regulated environment; System Audit / Validation background/experience; excellent… more
- DivIHN Integration Inc (Marion, NC)
- …and TrackWise Able to communicate optimally with supervisors and peers Knowledge of FDA quality system regulations is preferred Other Duties as Assigned This ... will help with real-time assessments and coordinate with other departments like quality operations, manufacturing, validation , etc, and the ability to collect… more
- Arthrex (Goleta, CA)
- …Treat Their Patients Better (TM) . We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the ... and block diagrams in support of production test processes. Partner with Quality Engineering in support of Quality Management System (QMS) requirements… more
- Novo Nordisk (Clayton, NC)
- …all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT , which globally employ approx. 20,000 of Novo Nordisk's 50,000 ... provide/lead validation services required for the successful delivery of IT & Automation projects. Relationships Senior Project Manager, Site Capacity & Upfit.… more
- Amgen (Holly Springs, NC)
- …part of Amgen's plan to be a carbon-neutral company by 2027. **Sr. QA Specialist- Quality Assurance Validation & Tech Support - Computer System Validation ... technical studies, and any associated documentation in support of CSV computer systems validation . + Provide quality guidance and support during fulfillment of… more
- Kelly Services (Gurnee, IL)
- …validation activities. **Qualifications:** **Education:** + Bachelor's degree in Quality Assurance, Life Sciences (eg, Biology, Chemistry, Biochemistry, etc.), ... and managing change control processes. **Skills:** + Strong understanding of GMP, FDA regulations, and validation principles. + Excellent written and verbal… more
- Bristol Myers Squibb (Bothell, WA)
- …and Engineering, IT , Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation ) to manage workload ... be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring...team. + Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations… more
- Teva Pharmaceuticals (West Chester, PA)
- …of Validation and Engineering/Commissioning experience. (Knowledge in validation and quality compliance (cGMP/cGLP/ICH/ FDA /USP/EU policies/guidelines.) ... Validation Engineer III Date: Aug 10, 2024 Location:...trouble accessing your EC account, please contact your local HR/ IT partner. **Teva's Equal Employment Opportunity Commitment** Teva Pharmaceuticals… more
- Kelly Services (Middletown, VA)
- …Pharmaceutical Industry supporting the manufacture of Regulated Products + Knowledge of validation in a FDA Regulated Environment. + Knowledge and understanding ... **Equipment Validation Engineer** + **Location** : (ONSITE) - Middleton,...standards (eg, 21 CFR Part 820, ISO 13485) & Quality tools (eg FMEA, Risk Analysis, Root Cause Analysis)… more
- Medtronic (Lafayette, CO)
- …lead a team of Test Engineers to develop and perform verification & validation activities for software and systems to ensure Medtronic's cutting edge medical ... products meet our user's needs and our quality and reliability standards. This position requires technical expertise and provides team leadership to solve complex… more
- ThermoFisher Scientific (Middleton, WI)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... departments and the client to initiate and complete performance qualification (PQ) validation . Facilitates the validation process and implementation of system… more
- Kelly Services (Arroyo, PR)
- …reports on assigned topics to appropriate personnel. * May train others in Quality Assurance/GMP/ FDA -QSR related topics, as a result of supplier changes * ... **Kelly(R) Engineering** is seeking ** Validation Specialist** for contract position at manufacturing client...and/or recommendation of fixtures, equipment and tools to ensure quality of our products, at minimal costs. * Develops… more
- AbbVie (North Chicago, IL)
- …regarding software validation /QA issues. + Act as a liaison between IT department and other Quality Control/Assurance departments. + Interface directly with ... Engineering or applicable discipline. + 5+ years' experience in validation , systems testing, IT implementation, quality assurance or software quality… more
- Kelly Services (St. Louis, MO)
- …a life science setting. + 3+ years of IT QA experience with regards to IT validation and FDA regulations + **Highly desirable skill includes IT ... (Software Development Lifecycle) and Regulated IT system/software validation , overseeing compliance and quality management for...all appropriate regulations and standards as they relate to IT , including FDA , ISO, HIPAA and GDPR,… more
- AbbVie (Waco, TX)
- …and maintains close relationships with key stakeholders in Manufacturing, engineering, quality . Validation , information security and global infrastructure. + ... treatments to positively impact in the role of Manufacturing BTS Manager, IT , you'll tackle complex you develop and diversify your professional experiences helping… more
- Medtronic (Minneapolis, MN)
- …within the US or onsite at a US-based Medtronic facility. As a Senior Principal IT Business Analyst on the Product DNA Execution team, you will be a key member ... of a multi-year Product Lifecycle Management enterprise IT program implementation team with a focus either on...their PLM Capability/Process area. + Plays key role in validation activities and usability pilots. + Strong industry /… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Our vision for the Director, Quality Assurance at BD** Lead the development, establishment and maintenance of Quality ... and controls during design, development, and transfer; ensuring that performance and quality of new products in Infusion business conform to product requirements,… more
