Duties and Responsibilities
· Provide management and direction to microbiologists in the laboratory.
· Ensure department metrics and cycle times are monitored the achievement 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 the in-process and release testing of raw materials and drug products. This individual will also provide QC microbiological guidance and support throughout the company.
· Manages 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 the 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.
· Conduct trouble-shooting and Out-of-Specification (OOS) investigations.
· Direct the efforts and study design for qualifying new utility systems and classified areas.
· Assist manufacturing and facility departments to solve microbiology related deviation issues.
· Assist in creation, implementation and administration of microbiology-based programs.
· Represent Quality Control (QC) during regulatory inspections to respond and address microbiology issues and solutions.
· Preparation of departmental SOPs to compliance to GMP and Good Microbiology practices.
· Provides leadership, management, and training and career coaching for QC staff.
· Conduct Technical and SOP training to the employees and monitor the practices.
· Responsible for the management, guidance and training of QC Team Leaders, Chemists, Microbiologists and Technicians.
· Develop the protocols and reports for the different validation studies to determine the Microbiology contamination in Manufacturing Environment, Water system, Compressed Air, Steam, Clean Gown and etc… to comply the GMP.
· Proficiency/experience with current USP microbial limits testing, USP sterility testing, USP antimicrobial effectiveness testing, environmental/personnel monitoring, identification of isolates, microbiological assays, validation and sterilization process, media growth promotion testing etc...
· Proficiency with managing panel organism cultures and slants.
· Supervise and manage multiple analysts (i.e. manage work assignments, review and release results.
· Provides broad-based QC Chemistry or Microbiology expertise and counsel to and on behalf of the organization.
· Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
· Participates in internal laboratory Audit and regulatory audits as required.
· Supporting the qualification and development of a contamination control program for new areas, equipment, systems etc… in compliance to the GMP.
Requirements and Qualifications
· You 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.
· You 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- it’s a mindset for everyone, every day to do better.
· If you are strong knowledge in the scope of work, GMP, passionate for working and open for new learnings.
· To be considered for this Quality Control (QC) Manager role you must 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.