Apex Life Sciences is looking for an individual who can work as a QC Analyst with one of our clients who is a mid-sized biotech company that has a facility sitting in Novato, CA. Details are below.
The Quality Control Microbiology, Environmental Monitoring, Analyst I under direct supervision, is responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment. With experience they would perform as a back-up for QC In-process and QC Microbial ID testing. Under direct supervision, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines.
In addition they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines.
The incumbent will be responsible for:
- Completing assignments in a timely manner
- Assisting with troubleshooting
- Assisting with data trending
- Follow-up on any testing issues or excursions
- Good record keeping, organizational, written and verbal communication skills are essential
- Supporting process validation studies
- Contributing to investigations
- Method validations
- Assay method/procedure development
- Reagent preparation
- In-process microbiological and analytical testing
- Growth promotion of media
- Microbiological identification testing
The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods.
The incumbent must be willing to work second shift, overtime, weekends, and holidays as required. Schedule will require all working hours: Sun-Thurs or Tues-Saturday.
- QC cGMP experience beneficial
- Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices
- Demonstrated working knowledge related to specific functional activities
- Ability to perform most tasks with supervision
- Computer literacy is required
- Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus
- Must have excellent record keeping, written and verbal skills
- Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays
- Efficient in scheduling and facilitating the execution of routine and non-routine testing
- Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience
- Associates of Science with at least 4 years of relevant laboratory experience
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.
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