QC Microbiology, Specialist

KEY RESPONSIBILITIES

• Write, review, and approve technical documents including SOPs, test methods, and reports.
• Perform equipment qualifications to support raw material, environmental, and product sample testing.
• Perform method qualification of various microbiological assays (Endotoxin, Mycoplasma, Sterility, etc).
• Troubleshoot method and analytical instrument issues.
• Train personnel on methods and equipment.
• Contribute to continuous improvement opportunities by optimizing EM and microbiological assay methods.
• Investigate invalid events, unexpected out of trend (OOT) and out of specification (OOS) test results. Author investigation reports while collaborating effectively with all impacted departments. 
• Write and ensure timely closure of non-conformance reports, and CAPA implementations.
• Maintain critical laboratory reagents needed to support method qualification, and routine microbiological assay testing.
• Perform routine release and stability testing, and environmental monitoring (EM) in cleanrooms and controlled areas as needed.
• Manage multiple projects, and work in a fast-spaced environment.
• Review QC data including environmental monitoring data and provide updates to Manufacturing, Quality Control, and Quality Assurance teams.

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 required.
• Experience with data processing software such as Excel, Word, PowerPoint is expected. 
• Strong understanding and knowledge of regulatory requirements and industry guidance and standards for Microbiological testing and Environmental Monitoring (USP, ISO, EU Annex etc.).
• The ability to operate for extended periods of time in a fully gowned, cleanroom environment is expected. 
• Ability to work both independently and in a team environment, multitask, and meet deadline 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.

Benefits

We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.

To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.

We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.