Details:
- Compensation: $95,000 - $105,000k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 21750
Summary of the position:
The QC Senior Microbiologist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.
The QC Senior Microbiologist is responsible for providing technical leadership and oversight for microbiological quality systems within an aseptic pharmaceutical manufacturing facility. This role supports sterility assurance programs, environmental monitoring, contamination investigations, and microbiological method execution in compliance with current Good Manufacturing Practices (cGMP), regulatory expectations, and internal quality standards.
Essential Functions & Responsibilities:
Education, Experience, and/or Skill:
Required Qualifications
Preferred Qualifications
The QC Senior Microbiologist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.
The QC Senior Microbiologist is responsible for providing technical leadership and oversight for microbiological quality systems within an aseptic pharmaceutical manufacturing facility. This role supports sterility assurance programs, environmental monitoring, contamination investigations, and microbiological method execution in compliance with current Good Manufacturing Practices (cGMP), regulatory expectations, and internal quality standards.
Essential Functions & Responsibilities:
- Provide microbiological oversight of aseptic manufacturing processes, including cleanroom operations, aseptic filling, and compounding activities
- Support sterility assurance programs, ensuring compliance with regulatory expectations
- Review and approve environmental monitoring (EM) data and trends for classified areas (ISO 5–8)
- Ensure viable and non-viable monitoring strategies are appropriate for aseptic conditions
- Lead environmental monitoring programs, including routine sampling, excursion response, and data trending
- Evaluate EM data for adverse trends and implement corrective/preventive actions (CAPAs)
- Maintain alert and action limit systems aligned with historical data and regulatory expectations
- Author periodic microbiological trend reports for quality review
- Lead microbiological investigations related to out-of-specification (OOS), out-of-trend (OOT), sterility failures, and contamination events
- Perform root cause analysis using established investigation tools and methodologies
- Provide scientifically sound conclusions and recommendations to prevent recurrence
- Support contamination control strategy (CCS) development and continuous improvement
- Ensure laboratory activities comply with cGMP, data integrity principles, and GDP (Good Documentation Practices)
- Oversee method validation, verification, and suitability activities
- Serve as subject matter expert (SME) for microbiological and aseptic processing topics
- Provide technical guidance and training to junior microbiologists and manufacturing personnel
- Drive continuous improvement initiatives to strengthen contamination prevention and microbiological control
- Provide training, mentoring, and technical guidance to microbiologists on aseptic techniques, microbiological methods, and cGMP compliance to ensure consistent execution of laboratory and environmental monitoring activities
- Evaluate and implement new technologies and methodologies for microbiological testing and environmental monitoring
- Performs other duties as assigned by management
- Provide microbiological support for special projects, including facility upgrades, equipment qualification, and implementation of new aseptic technologies
- Participate in cross-functional initiatives with Manufacturing, Quality Assurance, and Validation to enhance contamination control strategies
- Assist in the evaluation and selection of contract laboratories or external testing services as needed
- Contribute to the development and delivery of microbiology and aseptic technique training programs for site personnel
- Support internal committees or working groups focused on quality improvement, deviation reduction, or inspection readiness
- Review and provide input on facility design, cleanroom modifications, and material/personnel flow to ensure alignment with aseptic processing principles
- Participate in industry forums, professional organizations, or benchmarking activities to maintain awareness of current microbiological and regulatory best practices
- Provide on-call or after-hours technical support for critical microbiological or aseptic manufacturing issues, as required
- Assist with preparation of regulatory filings, responses, or technical justifications related to microbiological control systems
Education, Experience, and/or Skill:
Required Qualifications
- Bachelor’s degree in Microbiology, Biology, or a related life science
- Minimum of 5–8 years of microbiology experience in a pharmaceutical, biotechnology, or aseptic/terminal sterilization manufacturing environment conducting assays including, but not limited to: bioburden, bacterial endotoxin testing, sterility testing, growth promoting testing, basic bacterial staining techniques (e.g. gram. spore), Environmental Monitoring (cleanrooms, water systems, compressed gases).
- Demonstrated experience supporting aseptic processing/terminal sterilization cleanroom operations
Preferred Qualifications
- Master’s degree in Microbiology or a related life science
- Experience supporting or participating in regulatory inspections (e.g., FDA, EMA, or equivalent)
- Capable of interpreting the microbiology, sterility assurance, and contamination control aspects of EU,PIC/S Annex I