Job details
The QC Microbiology Environmental Monitoring (EM) Specialist is responsible for maintaining the quality and integrity of manufacturing facilities and processes. This role focuses on supporting environmental monitoring programs, cleaning and maintaining cleanrooms, and ensuring strict compliance with regulatory requirements. The specialist collaborates with cross-functional teams to identify contamination risks and helps develop protocols to safeguard product quality. ...
Responsibilities:
Environmental Monitoring Execution (30%): Conduct routine monitoring of cleanrooms (viable/non-viable air sampling, surface, and personnel monitoring). This includes plating samples, ensuring proper incubation, reading plates for microbial growth, and analyzing data for trends or deviations.
Cleanroom Cleaning & Maintenance (20%): Perform scheduled cleaning of controlled areas according to established protocols. Ensure all activities are documented and verified in compliance with GMP standards.
Reporting & Data Management (10%): Prepare EM reports, document findings, and recommend corrective actions while maintaining records in accordance with GMP.
Compliance & Audits (10%): Ensure adherence to FDA, EMA, and ISO standards. Assist in audits and inspections conducted by regulatory agencies, clients, or internal quality teams.
Procedure Development (10%): Develop, review, and revise Standard Operating Procedures (SOPs) related to EM and cleanroom maintenance.
Collaboration & Communication (10%): Work with QC, QA, and Manufacturing teams to review results, identify risks, and implement corrective actions.
Training (5%): Provide training to staff on EM techniques, cleaning procedures, and compliance requirements.
Working hours: 8:00 AM - 5:00 PM
Skills:
Certifications: Relevant certifications such as Certified Quality Auditor or Certified Microbial Analyst are considered a plus.
Experience: Highly desirable to have specific experience with environmental monitoring in ISO classifications and EU Graded cleanrooms.
Qualities: Proactive, self-motivated, and team-oriented with a strong commitment to safety and the ability to thrive in a fast-paced environment.
Education:
Bachelors
Experience:
1-4 years
Qualifications:
Education: Bachelor's degree in microbiology, biology, environmental science, or a related field (preferred).
Experience: 1-3 years of experience in environmental monitoring, cleanroom cleaning/maintenance, or quality control within a biotech or pharmaceutical setting.
Knowledge: Strong understanding of cGMP regulations, ISO classifications, and EU Graded cleanroom environments.
Technical Skills: Proficiency in microbiological techniques, data analysis, and statistical methods for trend analysis.
Physical Requirements: Ability to perform frequent gowning, standing, walking, and fine motor tasks; must be able to lift up to 30 lbs.