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location: Berkeley, California
job type: Contract
salary: $29.84 - 35.11 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
DESCRIPTION-
Quality Control Microbiology - Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release.
POSITION SUMMARY-
This position is to support related QC Assay testing/validation for Inspire-01 project.
POSITION DUTIES & RESPONSIBILITIES
- Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical and development products. Responsibility including protocol and report write up.
- Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
- Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
- Investigates questionable test results, writes protocol deviation report (PDR), investigation/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
- Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, revises SOP's affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
- Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
- Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
- Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
- Prior experience in a QC microbiology testing laboratory.
- Ability to work independently with minimum supervision.
qualifications:
REQUIREMENTS/PREFERENCES
Education Requirement(s):
- Minimum Education bachelor's degree in microbiology or related science degree or technical field.
- Minimum Experience 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
skills: Quality control, MS-WORD, CAPA, MS-EXCEL, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
