Product Release Coordinator
$60,611–$75,854 year
On-site · Los Angeles, California, United States
Job Summary
Product Release Coordinator responsible for the review of manufacturing batch documentation and the preparation of product releases and submissions to regulatory agencies. Performs detailed audits of manufacturing batch documentation, monitors documentation error rates, prepares verifications for Release office functions (intermediate product release, label authorization, distributions release), prepares product certifications for customers and submissions to regulatory agencies, communicates with multiple departments to ensure release and submission reviews, adheres to FDA regulations and maintains documentation quality, trains entry level personnel, and collaborates across functions in a 24/7 plant environment. Proficiency with SAP and MS Office is expected; excellent verbal and written communication in English required.
Required Qualifications
- Bachelor’s degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline
- Minimum of 2 years of related quality / product release experience in a pharmaceutical, GMP, or FDA regulated environment
- Equivalency – depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered
- Requires an in-depth understanding of pharmaceutical manufacturing, and quality review relating to production batch records
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines
- Ability to work independently with minimum supervision
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis
- Must be proactive, results oriented, and have strong attention to detail
- Self-starter with strong work ethic and the ability to exercise good judgment
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment
- Excellent verbal and written communication skills in the English language
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Specific experience with SAP is preferred
- Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation
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