Grifols Shared Services North America, Inc Principal Scientist - QC Microbiology 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.
Incumbent will work with other Quality Control (QC) team members to develop general microbiology testing methods, and will work to identify and implement new procedures, as well as optimize existing processes.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Oversee QC microbial identification lab, performing microbial identification.
Develop and validate new methods or modify existing methods.
Optimize existing procedures and implement new procedures for quality control testing of plasma protein products.
Initiate and write technical reports and update laboratory procedures.
Establish and maintain databases. Generate trending reports as needed.
Provide scientific information and perform scientific studies, when necessary, to support investigations.
Provide basic microbiology training and support for employees in the company.
As required for regulatory submissions, design and oversee performance of validation studies.
Write protocols and reports for the validation studies, act as study director for the studies, assist with performance of the studies and ensure that studies are performed according to Good Laboratory Practices (GLPs).
Work with other members of the QC and manufacturing groups to develop and implement processes that will improve the testing efficiency of plasma products and enhance plasma product quality.
Communicate technical activities (both verbally and in writing) to all levels within the company.
Provide technical advice and counsel regarding projects as needed.
Maintain current knowledge of regulatory and industry standards, trends, and advancements.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for areas of responsibility as deemed necessary.
Maintain current knowledge of regulatory and industry standards, trends and advancements.
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.
A Ph.D. in Microbiology with focus in microbial ecology, environmental microbiology or related field, or a M.S. in Microbiology with 5 to 7 years of experience in the pharmaceutical/food industry.
Experience in an FDA regulated laboratory facility – (pharmaceutical, biologics, biotech, or medical) is highly preferred.
Working knowledge of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines is preferred.
The successful candidate must have knowledge in isolation and identification of bacteria and fungi.
Knowledge of mycology, clinical/veterinary microbiology, epidemiology and bacterial endotoxins is helpful.
Experience in method development is desirable. Strong technical report writing is required.
Must be able to make scientifically sound decisions on preventing the recurrence of microbial contaminations in pharmaceutical environments using information derived through experiments conducted in the laboratory, environmental monitoring data, or through searching literature database.
Strong organizational and decision making skills.
Strong interpersonal and communication skills with ability to interact with all levels of personnel in a professional manner.
Proficient in computer use (Word, Excel, PowerPoint, internet) with ability to learn new computer applications.
Excellent verbal and written communication. Must be able to read, write, and speak English. Must have strong technical writing skills.
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
Must be proactive, results oriented, and have strong attention to detail.
Ability to keep neat, accurate and complete records and logs.
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: 285608