Specialist, Quality Control Microbiology

Role Summary

The Specialist, Quality Control Microbiology, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production. The Specialist, Quality Control Microbiology performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility, data review and report writing.

Responsibilities

• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Ensure schedule adherence aligns with department goals and manufacturing support. Escalate as needed.
• Support department risk assessments and participates in audit walk-throughs.
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Escalate issues with multiple solutions to management when timelines are at risk
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• Proficient in investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Trend Reports for QC.
• Oversees special projects on microbial and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Performs training of departmental personnel in appropriate technique and related topics.
• Mentor Analyst/Sr. Analyst level to ensure strong teamwork.
• Champion’s continuous improvement projects both internal and cross-functional, to maximize laboratory/site efficiencies and to strengthen compliance.
• Other related job duties as assigned.

Qualifications

• Minimum 5 years’ experience in a GMP environment.
• Excellent interpersonal, verbal, and written communication skills with strong technical writing experience.
• Possess a strong understanding of QC testing technique.
• Proficient in Microsoft Word, Excel, Power Point and other applications.
• Extensive knowledge of GLP and GDocP principles.
• An understanding of FDA/EMEA regulations.
• Languages: English.

Education

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field

Skills

• Proactively raise concerns to management with multiple solutions.
• Acts as SME on cross functional teams and inspection support.
• Full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Ability to receive little instruction on day-to-day work, general instructions on new assignments.
• Networks with senior internal and external personnel in own area of expertise.