Quality Inspector, QC Unit

The Quality Inspector is responsible for maintaining Environmental Monitoring (EM) programs in compliance with internal standards and regulatory requirements (e.g., HPFBI, FDA, EU).

This role ensures environmental controls are met to maintain classified cleanroom conditions and oversee critical aseptic activities during production.

Key Responsibilities

• Plan, schedule, and perform all environmental monitoring tasks to support testing of classified cleanrooms, aseptic operators, and critical utilities.
• Conduct environmental monitoring during aseptic filling activities and oversee these operations to identify and report any deficiencies.
• Perform sampling and Acceptable Quality Limit (AQL) inspections on filled products within the aseptic core.
• Adhere to prescribed testing methods, protocols, and cGMP standards while executing environmental monitoring duties.
• Maintain accurate, legible, and complete records of all tests, instrument readings, and observations, ensuring data integrity and traceability.
• Promptly notify supervisors of out-of-specification results, out-of-trend conditions, or any irregularities in testing.
• Support troubleshooting activities, training initiatives, and participate in investigations as needed.
• Perform additional tasks as delegated by supervisory staff.
  
  

DEC or BSc in Microbiology or a closely related field.

Experience

• Experience in a microbiology lab setting, ideally within quality control or R&D.
• Hands-on experience with microbial testing in cleanrooms, aseptic environments, and critical utility systems.
• In-depth understanding of compendia (USP, EP, BP) and application of cGMP in laboratory and production environments.
• Proficient in Microsoft Office, SAP, and Electronic Data Acquisition Systems.
• Strong technical writing and documentation skills.
• Bilingual capability in French and English, with proficiency in English being essential.
  
  

If you would like to learn more about this great opportunity, please email and reference job# 19353.