Job Information
Grifols Shared Services North America, Inc Product Release Coordinator 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.
POSITION SUMMARY
Responsible for the review of manufacturing batch documentation and the preparation of product releases and submissions to regulatory agencies.
ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.
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.
Trains entry level personnel.
Performs more complex and advanced job tasks.
REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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.
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.
PHYSICAL REQUIREMENTS
Ability to lift /move up to 25 pounds.
Ability to sit for extended periods - up to four (4) hours at a time.
Manual dexterity to perform all job functions.
The estimated pay scale for the Product Release Coordinator 1 role based in Los Angeles, CA, is $28.30 - $30.00/ 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, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “
*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.
Req ID: 518967
Type: Regular Full-Time
Job Category: Quality