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. Job Summary:
Responsible for ensuring that all required product tests are validated in a timely and GMP-compliant manner. Essential Job Duties:
- Develops new biochemical and microbiological methods for testing Grifols products and process samples.
- Designs protocols for validating existing and new test methods and supervises execution of these protocols.
- Assists in the transfer of validated methods to the Grifols QC laboratory.
- Assists in developing and maintaining a schedule for the validation of QC tests for process intermediates and final product.
- Designs protocols for installation, operation and performance qualifications of new QC analytical instruments and maintains the schedule for completing these qualifications.
- Identifies resources, equipment and supplies that are required to perform validation of process intermediate and final product tests.
- Maintains system for timely purchase and qualification of laboratory equipment and reagents.
- Reviews and revises standard operating procedures for technical accuracy and compliance with regulatory requirements.
- Assists the QC department in troubleshooting or investigating instrument and assay problems.
- Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement.
- Maintain current knowledge of regulatory and industry standards.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA regulations.
- Adhere to departmental corporate safety policies.
- Ph.D. in Chemistry, Biochemistry, Biology or closely related scientific discipline is preferred.
- Related experience in laboratory methods validation and familiarity with ICH and U.S. / European pharmacopeia guidelines for analytical methods validation is strongly preferred.
- Equivalency: In lieu of a Ph.D., candidate must have a Master's degree and a minimum of 5 years of related methods validation experience in a pharmaceutical, GMP, or FDA regulated environment.
- Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA.
- Requires a familiarity with statistical methods for data analysis.
- Must have strong technical writing skills.
- 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 LIMS is preferred.
- 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: