QC Microbiology, Specialist (Contract)

QC Microbiology, Specialist (Contract)

Location: Redwood City, CA

We are currently seeking an energetic and experienced candidate with a background in microbiology and cleanroom environment to join our Quality Control Development (QC) team as a QC Microbiology Specialist. The successful candidate will contribute to the advancement of our product pipeline by editing technical documents, qualifying QC microbiology methods, performing in-house sample analysis, and other assigned tasks. The individual will also be expected to independently organize, analyze, and present results and conclusions.

KEY RESPONSIBILITIES

• Review and approve technical documents including SOPs, Test methods, protocols, and reports.

• Perform equipment qualifications to support product, raw materials, environmental and utility sample testing.

• Perform method qualification of microbiological assays (Endotoxin, Mycoplasma, Sterility, etc).

• Troubleshoot method and analytical instrument issues.

• Train personnel on method and equipment.

• Contribute to continuous improvement opportunities by optimizing EM and Microbiology assay methods.

• Investigate invalid events, unexpected Out of Trend and Out of Specification test results. Write the investigation report while collaborating effectively with all impacted departments.

• Write and ensure timely closure of non-conformance, and CAPA implementation.

• Maintain critical laboratory reagents needed to support method qualification, and routine microbiological assay testing.

• Perform routine release and stability testing as needed.

• Perform environmental monitoring (EM) in cleanrooms and controlled areas as needed.

• Perform growth promotion testing as needed.

• Manage multiple projects, and work in a fast-spaced environment.

• Review QC data including Environmental Monitoring data.

QUALIFICATIONS:

• BS or MS in biological sciences or a related field is required.

• 3 years of relevant experience in Microbiology laboratory and cleanroom manufacturing environment.

• Experience/familiarity with various microbiology methods, such as endotoxin, mycoplasma, sterility, growth promotion environmental monitoring, is desirable.

• Experience with data processing software such as Excel, Word, PowerPoint is desirable.

• Strong understanding and knowledge of regulatory requirements and industry guidance for Microbiological testing and Environmental Monitoring (USP, ISO, EU Annex etc).

• The ability to operate for lengthy periods of time while gowning in cleanroom environment is expected.

• Experience in drafting documents such as SOPs or reports is desirable.

• Ability to work both independently and in a team environment, multitask and meet deadlines in a fast-paced environment.

• High initiative, organized, and conscientious record keeping skills, strong attention to detail.

• Excellent verbal and written communication skills.

• Ability to utilize troubleshooting and problem-solving skills.