QC Manager

Job Description

• Provide management and direction to microbiologists in the laboratory.
• Ensure department metrics and cycle times are achieved and Maintain product timelines.
• Manage the activities for the QC microbiology group and ensure quality standards for their pharmaceutical and device products. Oversight of the Environmental Monitoring program as well as in-process and release testing of raw materials and drug products. This individual will also provide QC microbiological guidance and support throughout the company.
• Manage the Quality Control Chemistry or Microbiology laboratory operation, ensuring laboratory processes provide high quality analytical support for manufacturing, maintenance, engineering and validation operations while ensuring compliance of protocols, GMPs, and safety regulations.
• Control and conduct sample, sample analysis, review the results.
• Ensure compliance in microbiology lab to meet the GMP and GLP requirements for national and international standards including ISO17025, ISO9001.
• Maintain the reference standards, standard strains, media and laboratory requirement.
• Review the test reports, raw data, and records approval of the same.
• Review and maintain the inventory of the departmental consumables and manage department budget.
• Execute and Monitor environmental monitoring and testing schedule, progress, data and work quality.

Job Requirements

• Mandatory to have a B.Sc. in microbiology or closely related field with at least 7 years experience in a microbiology lab, preferably in the pharmaceutical or biotech industry, with 3-5 years of that experience in a leadership role in microbiology laboratory management.
• Enjoy leading and motivating a team to accomplish great things.
• Excel at building and navigating cross functional relationships with the ability to influence in a positive manner.
• Handle issues appropriately and with a sense of urgency.
• Want to challenge the status-quo and foster a culture where continuous improvement is not just a metric- its a mindset for everyone, every day to do better.
• Strong knowledge in the scope of work, GMP, passionate for working and open for new learnings.
• Proficient in Burmese and English