Grifols Shared Services North America, Inc Product Release Coordinator 1 in Los Angeles, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Responsible for the review of manufacturing batch documentation and the preparation of product releases and submissions to regulatory agencies.
Essential Job Duties:
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.
Bachelor's Degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline is required.
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.
This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 288327