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Flushing, NY
... in Macy’s Valley Stream ●Proficient in working with Current Good Manufacturing Practices (cGMP), FDA, OPDP, and PDUFA ●Served clients such as, Astra Zeneca, DuPont Pharma, GlaxoSmithkline, Merck, Pfizer, Dey, Acorda, Actavis, Stiefel Pharma, Eisai, ...
- 2023 Aug 01
Newark, NJ
... ●Maintain GMP and cGMP compliance to meet regulatory requirements of the FDA. ●Document processes and SAP functionality – processes, flowcharts, procedures, work instructions, configurations. Support SAP Core Model ●Review master batch records, ...
- 2023 Jul 27
Teaneck, NJ
... ● Aided Quality Assurance department with generating graphic supporting material for FDA product submissions. ● Coordinated product mockups and graphics for investor presentations. ● Responsible for CAD software upgrades and maintenance. JCDecaux ...
- 2023 Jul 21
West New York, NJ
... Good working knowledge of FDA, and GCP regulations and guidelines and hands on experience in implementing CDISC/SDTM standards and Define.xml, along with efficacy. Developed and used SAS MACROS programs and modified existing SAS programs to make ...
- 2023 Jul 20
The Bronx, NY
... Research Study Participant Self-employed Jul 2018 – Aug 2019 ● Participated in research medical studies about not approved FDA drugs Certified Nursing Assistant Bronx Gardens Rehabilitation Center, Bronx, NY Jan 2018 – Jun 2018 ● Observed and ...
- 2023 Jul 14
New York, NY
... ●Participated in internal and external audits and FDA inspections. ●Supervised line clearance before production. ●Sustained clearance of end of production line. ●Acted as Head of Quality when requested. ●Supervised department employees for proper ...
- 2023 Jul 13
New York, NY
... In every stage, maintaining SOPs, company standards and FDA. Approved vacation time of QA as per requirements. Check QA clockin and clockout & any irregularities need to fix. Examining tablets hardness, thickness, color & friability according to the ...
- 2023 Jul 10
Carlstadt, NJ
... 2021 to Present Henry Schein Dental – Moonachie, NJ • Assist three Regional Operations Mangers with submitting all 2579 FDA Forms to the FDA, State and Henry Schein customers for x-rays installed by the New York, New Jersey, and Long Island centers. ...
- 2023 Jul 10
Flushing, NY
... Roche, P & G for Regulatory, R&D, Clinical Trial, Clinical, CRO, Pharmacovigilance, Life Science Commercial Sales & Marketing, Oncology, CNS, Neuro, Auto Immune, Vision, FDA, Finance, Information Technology and LS Manufacturing & Supply Chain. ...
- 2023 Jul 03
Stamford, CT
... #46146587 2019, CITI: Good Clinical Practice Course (US FDA focus), Cert. Ref. #30913728 Other Awards/Accomplishments Passed an Occupational English Test (2022) Received a community leadership award for exemplary commitment to working ...
- 2023 Jun 29