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Sept or Staten or FDA jobs in Columbus, OH, 43215

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Development Process Engineer

Experis  –  Columbus, OH, 43219
... Ensure compliance of process parameters and operational conditions with USDA and FDA regulations. Refer to the detailed job description provided by the manager for specific duties. Skills: Minimum 1 year experience applying engineering knowledge in ... - May 08

Sr Computer System Validation (CSV) Engineer

Forge Biologics  –  Columbus, OH
... 211 Working knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 CFR Part 11 and Annex 11 regulations Must have strong attention to detail, be organized and proactive. ... - May 01

Machine Operator

KDC-Columbus  –  Groveport, OH
... Performs all work in a manner that is consistent with the company’s quality system and FDA good manufacturing practices, includes maintaining a clean and orderly production area at all times. Follows and promotes KDC’s safety and environmental ... - Apr 17

Associate Director, Manufacturing (GMP)

Amplifybio, LLC  –  New Albany, OH, 43054
... GMP Compliance: Oversee all manufacturing activities to ensure compliance with GMP regulations, FDA guidelines, and industry standards specific to cell and gene therapy. Adhere to robust quality systems, including batch record review, deviation ... - May 02

Quality Assurance Manager

T. Marzetti Company  –  Columbus, OH
... preferred: Preventive Controls Qualified Individual (PCQI), HACCP (16-Hour), Internal Auditor Training (FSSC22000/ISO, BRC) Prior experience handling third-party audits, customer audits, and regulatory inspections (FDA/USDA) strongly preferred. ... - May 02

Pharmaceutical Field Sales Representative

Tailstorm Health Inc.  –  Columbus, OH
... Company focuses on molecules and products that are on FDA’s shortage list. Current molecules being sold to hospitals are Sterile water, Sodium Chloride, Lidocaine, Bupivacaine and a few more. Company will be expanding its range to 15 molecules by ... - Apr 15

Medical Reviewer/Safety Reviewer - A

Intellectt INC  –  Columbus, OH
... In depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom ... - May 06

Regulatory Project Coordinator - Regulatory Affairs Administration

Nationwide Children's Hospital  –  Columbus, OH
... This position is responsible for maintaining relevant records through the database, and preparing reports on FDA-regulated clinical trial activity. This position is also responsible for interactions with external clients (project management, billing ... - Apr 30

Regulatory Project Coordinator - Regulatory Affairs Administration

Nationwide Children's Hospital  –  Columbus, OH, 43215
... This position is responsible for maintaining relevant records through the database, and preparing reports on FDA-regulated clinical trial activity. This position is also responsible for interactions with external clients (project management, billing ... - Apr 29

Head of Quality

Andelyn Biosciences  –  Columbus, OH, 43215
... The Head of Quality is to ensure compliance with current US FDA, EMA, and relevant ICH guidance documents. Ensure the Quality Organization is appropriately resourced and effectively executing a required state of quality and CGMP compliance. The role ... - Apr 27
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