- Perform microbiological (AML) and endotoxin (LAL) testing on water samples, in-process product samples, raw materials, and environmental monitoring (EM) samples as directed by the laboratory supervisor or Senior Microbiologist.
- Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
- Count colony forming units (CFU) on Petri plates.
- Perform sterility testing on final products and raw materials.
- Perform Growth Promotion and Biological Indicator testing.
- Isolate and maintain pure microbial cultures from test samples.
- Prepare and maintain frozen cultures of microbial isolates.
- Perform various microbial identification tests (microscopy, genetic, biochemical, and/or morphological).
- Maintain microbial identification database.
- Compile and enter data into computer database (i.e. LIMS - Laboratory Information Management Systems) to be used for reporting and trending purposes.
- Review test results against specifications.
- Will share general responsibilities for laboratory equipment maintenance and calibration, housekeeping, and other lab support functions (e.g., inventory of consumables and reagents).
- Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- 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 Microbiology, Biology, or closely related scientific discipline is required.
- Related experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is preferred.
- Requires a basic understanding of the fundamentals of microbiology, aseptic techniques, isolation and identification of molds, yeasts, and bacteria, as well as basic statistical analysis.
- 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 (Laboratory Information Management System) is preferred.
- Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
- Ability to lift /move up to 25 pounds.
- Ability to stand for extended periods - up to four (4) hours at a time.
- Manual dexterity to perform all job functions.
- Exposure to toxic/caustic chemicals and biological hazards.
- Must have color perception/discrimination for inspection and/or testing.
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QC Microbiologist - Los Angeles, United States - GRIFOLS, S.A.
Description
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
The Microbiologist 1 is responsible for performing various microbiological tests of raw materials, in-process, final bulk and final container product, as well as environmental monitoring samples.
ESSENTIAL DUTIES & RESPONSIBILITIES include the following. Other duties may be assigned.
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.
*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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-Los Angeles:US403 - LA CA-QC Building
Learn more about Grifols