Senior QC Microbiologist

Key Accountabilities/Core Job Responsibilities:
- Implement and execute microbiological testing.
- Support the development and implementation of USP methods for sample testing and environmental monitoring processes throughout the facility.
- Support “on-floor” operations such as investigations.
- Generate, review, and report/approve data as required.
- Undertake facility environmental trend reporting.
- Review documentation for product disposition; generate CoA’s and batch summary reports.
- Provide disposition recommendations and support investigations as required.
- Serve as a Microbiology subject matter expert.
- Work with accuracy, urgency, and a continuous improvement perspective.

Qualifications/Skills:
- Typically requires a BS in Biology or Microbiology and 8+ years of experience in Pharmaceutical or Biotech Microbiology.
- Familiarity with USP test method qualifications and execution.
- Familiarity with Environmental Monitoring.
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance.
- Ability to work independently.
- Well-developed verbal and written communication skills.
- Ability to closely follow quality standards with attention to detail.
- Strong collaboration skills.
- Excellence in execution (accuracy, “right first time,” proactive nature).
- Ability to learn quickly and driven by high curiosity.
- Physical requirements: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand for multiple hours at a time.

Benefits (explicitly stated):
- Competitive total rewards package including 401k, healthcare coverage, ESPP, and other benefits.

Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers