- Cedars-Sinai (Los Angeles, CA)
- …collaborates with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies, including the Food and ... Drug Administration ( FDA ) and local Institutional Review Board. Primary Duties and...and presenting findings to support study objectives and data quality initiatives. + Identifies and resolves operational/data problems, recommending… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …activities for the organization's Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements ( FDA , EMA, etc.). * ... and QA Lead will be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This… more
- United Therapeutics (Silver Spring, MD)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... **Who You Are** You'll play an integral part in ensuring the compliance and performance of critical manufacturing systems-including QC lab equipment, and upstream,… more
- Actalent (St. Paul, MN)
- …+ Drive risk management activities, including FMEA and fault-tree analysis, ensuring compliance with regulatory and quality standards. + Support design transfer ... components for medical devices. You will work cross-functionally with R&D, Quality , Regulatory, Product Management, and Manufacturing teams to ensure products meet… more
- Actalent (Orlando, FL)
- …HPLC, GC, and other analytical equipment. Ensure compliance with cGMP, FDA , and internal quality standards. Document and report analytical results accurately ... assist in regulatory inspections. Collaborate with cross-functional teams including Quality Assurance, Production, and R&D. Skills Chemistry, Hplc, Wet chemistry,… more
- Philips (Colorado Springs, CO)
- …RA Management. + Obtaining knowledge in global regulatory requirements. + Following Spectranetics Quality System procedures to ensure compliance with US CFR, ISO ... CMDR, MDSAP and all other applicable regulations. + Applying FDA , ISO, EU, and other applicable regional regulations **You're...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- Medtronic (Brooklyn Center, MN)
- …implement advanced controls strategies, and collaborate across teams to deliver high- quality products that meet Medtronic's standards of innovation and patient care. ... strategies to improve efficiency, reduce downtime, and enhance product quality . + **Troubleshooting and Maintenance:** Provide technical expertise in diagnosing… more
- Charles River Laboratories (Reno, NV)
- …and submitted as required + Oversee responses to internal/external inspections and quality assurance audits of veterinary or animal welfare type content + ... expert veterinary research support to Study Directors and Sponsors + Maintain compliance with all applicable laws and regulations including the Animal Welfare Act… more
- Catalent Pharma Solutions (Harmans, MD)
- …- Wednesday.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and ... of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Actalent (Minneapolis, MN)
- …product development initiatives for disposable medical devices. + Ensure compliance with FDA Design Controls and ISO Quality Management Systems. + Apply risk ... Six Sigma (DFSS) is highly desirable. + Experience with FDA Design Controls and ISO Quality Management...Experience with FDA Design Controls and ISO Quality Management Systems. + Familiarity with ANSI/AAMI/ISO standards related… more