QC Microbiologist I

QC Microbiologist I

Requirements

• Bachelor’s degree required.
• 04-06 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Secrecy and invention agreement and non-compete agreement
• Ability to work non-standard schedule as needed

Responsibilities

• Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.
• Direct responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS result.
• Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.
• Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.
• Participates in projects, task force jointly with production personnel in case the needs arise.
• Prepares trend analysis and data compilation on deviation in the production process when required.
• Participates in internal and external audit.
• Participates in the Global Microbiology Task Team, whenever required.
• Responsible in microbiological release of medical devices or Pharma products and Pharma incoming materials.
• Supports microbiological tasks for process validation.
• Trains and proactively develops the education standard of the responsible persons.

Preferred Qualifications

• Applicable industry/professional certification preferred.