QC Microbiology, Specialist

QC Microbiology, Specialist  

We are currently seeking an energetic and experienced individual 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 Adicet’s product pipeline by writing 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

• Write, 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.
1000 Bridge Parkway, Redwood City, CA 94065 • Phone: 650.503.9095 • Fax: 650.771.9864
• 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.