- 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.
- 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.
- 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.
- Bachelor of Science degree.
- 0-3 years of relevant laboratory experience; QC specific experience is preferred.
-
Qc Analyst, Microbiology
3 weeks ago
BioMarin Novato, United StatesWho 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 cuttin ...
-
Microbiology Analyst
1 week ago
Tucker Parker Smith Group (TPS Group) Novato, United StatesQC Analyst · Location: Novato, CA. (On-Site) · 12 month assignment (Great potential to extend or convert) · Pay Rate: $28/hr. · Schedule: M-F, 1pm-11:30pm · On behalf of our client a leading pharmaceutical company specializing in developing therapeutics for patients with life thr ...
-
QC Analyst, Microbiology
3 weeks ago
Biomarin Pharmaceutical Inc. Novato, United StatesWho 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 cuttin ...
-
QC Analyst, Microbiology
1 week ago
BioMarin Pharmaceutical Novato, United States· 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 cu ...
-
QC Analyst, Microbiology
1 week ago
Biomarin Novato, United StatesWho 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 cutti ...
-
QC Analyst, Microbiology
1 week ago
Biomarin Novato, United StatesWho We Are · BioMarins 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 BioMarins cutting ...
-
QC Analyst, Microbiology
2 weeks ago
BioMarin Pharmaceutical Inc. Novato, United States Full timeWho 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 cutti ...
-
QC Analyst Microbiology
6 days ago
inSync Staffing Novato, United StatesSchedule (4 days/10 hours): · Sunday - Wednesday, swing shift (11:00am - 10:00pm) · Wednesday - Saturday, swing shift (11:00am - 10:00pm) · $30.00/hr - paid weekly · Job Duties · Perform daily environmental monitoring sampling of GMP facilities cleanrooms (Galli and Leveroni ...
-
3640 Analyst I, QC Microbiology
5 days ago
Harvest Technical Services, Inc. Novato, United StatesJob Description · Job DescriptionOnsite: Novato · PURPOSE · The QC Microbiology department 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 ...
-
3640 Analyst I, QC Microbiology
1 week ago
Harvest Technical Services, Inc. Novato, United StatesJob Description · Job DescriptionOnsite: Novato · PURPOSE · The QC Microbiology department 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 ...
-
Analyst I/II, Quality Control Microbiology
1 week ago
Bayside Solutions, Inc. San Francisco, United StatesWhy Work for Us Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our Micro, Biology, Quality Contr ...
-
Analyst, QC I
5 days ago
TALENT Software Services Novato, United StatesAnalyst, QC I · Job Summary: Talent Software Services is in search of an Analyst, QC I for a contract position in Novato, CA · The opportunity will be one year with a strong chance for a long-term extension · (Swing shift supporting the hours of · Position Summary: The Quality C ...
-
Quality Control Analyst
6 days ago
Planet Pharma Novato, United StatesDuties: · The Quality Control Analyst is responsible for performing microbiological/analytical 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 cli ...
-
Quality Control Analyst
6 days ago
Compass Consulting Novato, United StatesOur client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. · Job Summary: · The Quality Control Analyst is responsible for performing microbiological ...
-
Quality Control Analyst
6 days ago
Meet Novato, United StatesOur esteemed client, a leading pharmaceutical company known for its continuous growth, is seeking a Quality Control (QC) Analyst to join their dynamic team. In this pivotal position, you will play a key role in performing microbiological/analytical test methods on in-process inte ...
-
Quality Control Analyst
6 days ago
ProPhaGro2023 Novato, United StatesAnalyst I, QC Microbiology · Novato, CA · 12 month contract to start (benefits offered) · Pay: $25-28hr (W2 only- must be a US citizen) · PURPOSE · The QC Microbiology department is responsible for performing environmental monitoring and microbiological test methods on in-process ...
-
Quality Control Analyst
1 week ago
R&D Partners Novato, United StatesBiotechnology company is hiring two Quality Control Analyst to support manufacturing of commercial and clinical therapeutics. You will work a swing shift on Monday-Friday 1:00pm-9:30pm or first shift on Monday-Friday 8am-5pm. Both positions are eligible for shift differential. · ...
-
QC Analyst
6 days ago
Randstad Life Sciences US Novato, United StatesImmediate opening for a QC Analyst - Microbiology. The QC Microbiology department 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 guid ...
-
Quality Control Analyst
1 week ago
R&D Partners Novato, United StatesR&D Partners is seeking to hire an Analyst, QC I in Novato, CA. · Your main responsibilities as an Analyst, QC I: · The Quality Control Analyst is responsible for performing microbiological/analytical test methods on in-process intermediates and varying stages of drug products un ...
-
Analyst, QC I
1 week ago
Innova Solutions Novato, United StatesInnova Solutions is immediately hiring a Analyst, QC I · Position type: Full-time Contract · Duration: 12 months Contract · Location: Novato, CA · Shift: 1:00 PM to 9:30 OM · As a Analyst, QC I, you will: · Duties: The Quality Control Analyst is responsible for performing microbi ...
QC Analyst, Microbiology - Novato, United States - BioSpace
Description
Job DetailsWho 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
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.
&v=024){kind=logo}
