Analytical - R&D Metrology & Compliance Specialist I
R&D Metrology & Compliance Specialist GMP, SOP, FDA, USP -
Farmingdale/Commack, NY
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ce_Specialist_I
Analytical - R&D Metrology & Compliance Specialist I (ARD 121)
Analytical Research and Development
Farmingdale/Commack, NY
Description of Duties and Responsibilities:
· Candidate will help assist in the development of departmental quality
systems, interact with scientific and QA teams.
· Overall, individual will be key in managing instrumentation, working with
vendors and capturing critical data through electronic data systems while
maintaining overall compliance.
Requirements:
· BS/MS in scientific discipline (Analytical Chemistry preferred) with 2-4
years relevant experience focused on analytical support of drug development.
· Candidate would need a strong understanding of lab GMP's, SOP's, FDA trends,
USP, instrumentation, calibration and maintenance programs and the drug
development processes.
· Candidate should have strong communication and writing skills, while also
being effective at managing projects in a fast paced environment. .
· Knowledge of multiple laboratory techniques such as HPLC, GC, Dissolution as
well as knowledge of various software packages, Data Acquisition Systems, LIMS,
instrument and software validation is essential.
Opensoft Inc.
332 King St. W, Suite 201
Toronto, ON M5V 1J2
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