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FDA resumes in Swedesboro, NJ

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Production Supervisor Plant Manager

Wilmington, DE
... (The above job was a transfer still within DuPont) OTHER EXPERIENCE: FDA, CGMP, Six Sigma, Safety Committee, SAP, JD Edwards, Certified in Tech Drafting, Certified in First Aid and CPR, ISO Audit Training, Implemented TMS, CMM Training. TOOL AND ... - 2023 Dec 15

Quality Management System

Cherry Hill, NJ
... Documented product complaints into Quality Management Systems database for trending and responsible for investigating, completing, and maintaining Complaint Records in timely and accurate manner in accordance with the FDA's QSR Regulations, ISO ... - 2023 Dec 11

Administrative

Wilmington, DE
... 01/2014 – 03/2014 Cura Scripts/Express Scripts, New Castle, DE Administrative Assistant (temporary assignment) Input prescription numbers into RX Home System, print out prescription & label and attach for FDA auditing purposes, filing, and train new ... - 2023 Dec 10

Medical Device Surgical

Swedesboro, NJ
... Advance knowledge in FDA, EMA and PMDA regulatory compliance. Well versed in 21 CFR Part 803. Proficient in global GMP and Regulatory requirements. Working knowledge in CAPAs, INDs, recalls, QA, JDE, Literature, legal (litigations), clinical trials ... - 2023 Dec 08

Registered Pharmacist and Immunizer BCGP, PA, NJ, DE, VA

Philadelphia, PA
... Responsibility for clinical and operational compliance with USP 797, FDA, DEA, and PA BoP regulations Performed benefit appeals or other reimbursement/payer research, responded to CMS and PBM audits Took reports of and responded to: Assisted ... - 2023 Dec 05

Mechanical Hvac Fire Protection

Newark, DE
... Accountable for facility compliance with FDA, OSHA, and NFPA101 and NFPA110 codes. Allstates Technical Services, (Subsidiary of BE&K) Wilmington, DE 1994-1998 Senior Project Engineer/HVAC Consultant Project scope development, manpower forecasts, ... - 2023 Nov 29

Machine Operator Cnc Machinist

Philadelphia, PA
... in all aspects of Current Good Manufacturing Practices (CGMP), OSHA requirements and Standard Operating Procedures (SOP) for FDA Proficient in reading and interpreting Blueprints, Operational and Specification sheets Skilled in using measuring ... - 2023 Nov 19

Infectious Diseases Communication Skills

Berwyn, PA
... Responses to FDA queries IP claims and disclosures Clinical Study Reports (CSRs) Working on RAPS certification Presentations and posters Informed Consent Forms KEY ACCOMPLISHMENTS • Led publishing for 3 pipeline products, facilitating successful ... - 2023 Nov 17

Associate Director Statistical Programming

Philadelphia, PA
... Major Accomplishments: o Executed multiple FDA submissions for Vaccines and NS therapeutic areas. o Provided training and presentations to stakeholders and upper management on specifics of CBER requirements for Vaccines (SDSPs, Immunogenicity and ... - 2023 Nov 16

Project Manager Management

Philadelphia, PA
... Ensure all data meets HIPAA, FDA, CFR Part 11, and GDPR regulations. Led hiring efforts for several key roles for Salesforce developers, Product Manager/Project Manager, Architect and Business Analyst.) Conduct Monthly 1 on 1 with for Salesforce ... - 2023 Nov 13
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