Compliance Specialist III; Analytical Development
$87,000–$109,648 year
On-siteAlbany, New York, United States
Job Summary
Develop and maintain a strong command of SOPs, cGMPs, and associated regulations while monitoring compliance in Analytical laboratories and resolving quality issues. Assist Analytical staff with change control, CAPA processes, and deviations, then coordinate periodic review and revision of SOPs and equipment qualification documentation. Track and manage timelines for analytical quality events, representing the team during regulatory, client, and internal audits. Communicate with development chemists, Quality personnel, and management to identify quality system improvements and implement them. Perform all duties safely in accordance with Curia Safety Program, OSHA requirements, and FDA regulations.
Required Qualifications
- Master's degree
- Bachelor's degree
- minimum of three (3) years' or Bachelor's degree and minimum of five (5) years of industrial cGMP experience in an FDA-regulated pharmaceutical environment
- Proficiency in technical writing (e.g quality events, change controls, SOPs, protocols, reports, etc.)
- Knowledge of FDA and ICH guidance for pharmaceuticals
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Desired Qualifications
- Experience in Analytical instrument qualification and conducting investigations for Quality events
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