Product Release Coordinator

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Summary Responsible for the review of manufacturing batch documentation and the preparation of product releases and submissions to regulatory agencies. Essential Duties & Responsibilities Perform detailed audits of manufacturing batch documentation and resolve any issues with the appropriate personnel. Monitor documentation error rates of different departments by utilizing 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. Train entry‑level personnel. Perform more complex and advanced job tasks. Required Experience/Skills & Educational Qualifications Bachelor’s degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline is required. Minimum of 2 years of related quality/product release experience in a pharmaceutical, GMP, or FDA‑regulated environment is required. Equivalency – Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. 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. Occupational Demands Must be flexible with working hours/shifts in order to accommodate the 24‑hour, 7‑day plant operation. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2‑4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35 lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Benefits The estimated pay scale for Product Release Coordinator role based in California is $29.14–$36.42 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays, up to 5% 401(k) match, and tuition reimbursement. Location Location: North America, USA, California – Los Angeles: USVALLEY – Valley Bl Mfg Plant – LA, CA. Equal Employment Opportunity Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr Grifols