Product Release Coordinator
Los Angeles Metro Area, CA
Responsible for the review of manufacturing batch documentation and the preparation of product releases and submissions to regulatory agencies.
Perform detailed audits of manufacturing batch documentations and resolve any issues with the appropriate personnel.
Monitor documentation error rates of different departments by utilization of a database that requires updating on a daily basis.
Prepare and perform verifications for various Release office functions such as intermediate product release, label authorization, and distributions release.
Prepare product certifications for customers and submissions to regulatory agencies for various purposes.
Communicate with multiple departments to ensure product release and submission reviews.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Related quality / product release experience in a pharmaceutical, GMP, or FDA regulated environment is preferred.
Requires a basic understanding of pharmaceutical manufacturing, and quality review relating to production batch records.
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.
Bachelor's Degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline is required.