Quality Control Microbiologist

Germer International - Pharmaceutical Recruiting; Dayton (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting client seeks a QC Microbiology Analyst to support environmental monitoring in aseptic, classified, and controlled areas. The role includes documentation, change controls, risk assessments, and leading training.

The ideal candidate has 6+ years in cGMP labs/pharma quality, with strong technical writing, initiative, and collaboration skills. Some overtime and shift work may be required to align with manufacturing schedules.

Qualifications

• 6+ years of cGMP laboratory and/or Pharmaceutical Quality experience.
• Experience with environmental monitoring in aseptic, classified, and controlled areas.
• Experience preparing change controls, risk assessments, SOPs, protocols, final reports and support of discrepancies.
• Ability to perform work with minimal supervision and take initiative.
• Direct support of the manufacturing schedule, including potential overtime, weekend or shift work and holidays.
• Effective communication with co-workers, other departments, and management.
• Lead training on environmental monitoring, utilities, gowning, or aseptic practices.
• Audit support as needed.
• Act as department representative in meetings.

Responsibilities

• Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM).
• Direct support of the manufacturing schedule which may include overtime, weekend or shift work, and holidays.
• Audit support as needed.
• Act as department representative in meetings.

Skills

Technical writing

Self-starter

Communication

Team coordination

Education

Bachelor's/Associate in Biology or related field

Job description

Our client, a well established pharmaceutical organization is hiring a QC Microbiology Analyst to support their growing team. The ideal candidate will have experience in Environmental Monitoring.

Qualifications

• Technical writing skills which require minimal guidance from management
• Prepare documents such as change controls, risk assessments, SOP’s, protocols, final reports and support of discrepancies
• Gowning in an aseptic environment
• Self-starter that takes initiative to perform work with minimal supervision
• Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays
• Effective communication with co-workers, other departments, and management
• Lead training on environmental monitoring, utilities, gowning, or aseptic practices
• Audit support as needed
• Act as department representative in meetings

Education/Experience

Bachelors/Associates in Biology (or related field) or high school diploma with additional experience being substituted for a degree

• 6+ years of cGMP laboratory and/or Pharmaceutical Quality experience. Some college education may be substituted with additional years of relevant work experience.