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QC Analyst, Microbiology
4 months ago
Who We Are
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. TITLEQC Microbiology AnalystSUMMARYThe QC Analyst is responsible for performing environmental monitoring and microbiological test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Water testing, Endotoxin detection, Bioburden quantification, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation. RESPONSIBILITIES
- Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
- Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
- Execute microbiological methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
- Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
- Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
- Assist with monitoring and the control of laboratory supply and critical reagent inventories.
- Perform growth promotion of media and microbial identification testing.
- Qualify as trainer for specified methods, provide training to less experienced staff.
- Provide on call coverage to support oversight of QC laboratory equipment functionality.
- Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
- Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
- Perform other responsibilities as deemed necessary.EXPERIENCE Required Skills:
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
- Computer literacy is required, proficiency with Microsoft Word and Excel is essential,
- Must possess the ability to perform most tasks with minimal supervision.
- Desired Skills:
- Demonstrated working knowledge with respect to certified functional activities.
- Good documentation, written and verbal communication skills are essential.
- Experience with Microsoft PowerPoint, Access, or Visio is desired.
- Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
- EDUCATION
- Bachelor of Science degree.
- 0-3 years of relevant laboratory experience; QC specific experience is preferred. EQUIPMENTWill use environmental monitoring equipment and computers. Collection of samples will require lifting of light weights, 25 pounds from various facilities throughout the day. CONTACTSQC microbiology SHIFT DETAILSBack half swing Wed-Saturday 11am-10pm ONSITE, REMOTE, OR FLEXIBLEOn site only role. TRAVEL REQUIREDNo travel required.Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
