- Vaisala (Boston, MA)
- …budgets and maintain calculations and related documentation. Perform and analyze quality control checks. Review calibration certificates for accuracy and ... for both lab and field operations. Ensure compliance with the Quality Management System, ISO/IEC 17025, and ISO 9001. Interface with Regulatory Agencies and… more
- SOFIE (Miami Lakes, FL)
- …adhering to SOFIE's quality management system and maintain a state of cGMP control at the site. Ensure aseptic operations follow internal procedures ... dose management reports. Perform the duties associated with synthesis, quality control , and quality assurance...requirements, and FDA regulations. Ensure compliance with radiation and laboratory safety of the site, including the ability to… more
- SOFIE (Totowa, NJ)
- …on existing or new equipment. Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development ... to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212)....of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development… more
- Gilead Sciences, Inc. (Foster City, CA)
- … quality oversight for GMP activities within Analytical Development Operations and Quality Control at Gilead Foster City site, Contract Testing Laboratories, ... teams in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems and have extensive experience in managing contract… more
- Cresilon, Inc (New York, NY)
- …of testing methods to aid in exploratory research, product/process development, and quality control ; conduct chemical and mechanical property evaluation tests to ... distant activities. Preferred Qualifications An advanced technical degree (MS or PhD). Lab experience in an industry setting within cGMP -regulated environments.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …product. Additionally, they will be for responsible for ensuring that product quality targets and specifications are established for the projects they lead based ... effectively Recruit and hire new talent Accountable for: Developing analytical control strategies for drug substance and drug product, ensuring patient-centric… more
- Cedent Consulting Inc. (San Francisco, CA)
- …guidances. A strong attention to detail and demonstrated prior experience working in lab , GLP, and cGMP environment. Scientific excellence as demonstrated by ... analytical research and development scientist with a proven record of sustained laboratory achievement and innovation to join their growing CMC group. The candidate… more
- Cresilon, Inc (New York, NY)
- …and execute test methods to aid in exploratory research, product development, and quality control ; conduct chemical and mechanical property evaluation tests to ... and submit invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …support regulatory submissions (eg, IND, NDA, BLA). Support testing‑related product quality investigations, CAPAs, and change control activities. Communicate ... test method validation, and design verification. Familiarity with FDA regulations, cGMP standards, and design control for medical devices. Experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …product. Additionally, they will be accountable for ensuring that product quality targets and specifications are established based on robust patient-centric ... to QC, validations, and transfers, life-cycle management Developing analytical control strategies for drug substance and drug product, ensuring patient-centric… more
