Multiple Positions

Validation Associates LLC
Herndon, VA
Nov 21, 2021
Dec 05, 2021
Full Time
Mult. Pos at Herndon, VA: (1) Validation Engineer (6 pos): Analyze, design, build, test and troubleshoot various types of medical equip/analytical lab instruments for our clients in Life Sciences industry. Apply thorough knowledge of Validating Software & database sys's for medical & health care purposes, reqmnts gathering, risk analysis, test protocols generation (IQ, OQ, PQ), trace matrix, summary reports, including the cGMP and quality system regulations. Utilize FDA Compliance Regulations with cGxP standards, including 21 CFR Part 11/210/211/820, & OSHA. (2) Analytical Chemist, Quality Control (1 pos): Research, develop & perform analytical methods & perform quality cntrl testing activities; execute method validation & stability tests; execute laboratory tests/expmnts to support research & development activities; analyze & implement ICH guidelines & FDA regulations; draft & prepare submissions to FDA; assist in regulatory compliance audits; perform monthly calibrations of advanced analytical equip and apply knowledge of broad variety of analytical techniques; test drug substances, intermediates & raw materials; prevent & minimize errors while executing laboratory tests; assist in conducting troubleshooting processes & laboratory investigations; analyze & implement ICH guideline & FDA regulations, etc. All position requires Travel/relocate to various unanticipated locations to interact w/clients & train users for different short & long term projects. Mail resume to Validation Associates LLC, Attn: HR, 131 Elden St., Ste 204, Herndon, VA 20170.