Director of Microbiology Job

Director of Microbiology is needed to perform the following duties:

• Directs the supervision of all microbiological and environmental tests that are performed and reported in compliance with cGMP standards and in a timely manner.
• Overview, conducts, and/or delegates the final review and approval of environmental and microbiological test results including contract labs requirements before the documentation is forwarded to QA Batch Record reviewers.
• Oversee the review of compliance guidelines, industry trends, customer’s projects, validation efforts, and development efforts to ensure Microbiology/Environmental departments meet or exceed the minimum requirements.
• Represent the department and company in all Regulatory and customer audits.
• Oversee the timely completion of projects, CAPAs, and investigations.
• Oversee and assures that the departmental training program meets Company standards.
• Oversee and review responses compliance audits/deficiencies and CAPA plans of areas of responsibility.
• Oversee the coordination of development and validation of microbiological methods.
• Perform employee performance appraisals in a timely
• Oversee and conduct the hiring process of new personnel for the Microbiology and/or Environmental departments.
• Oversee and/or ensures all laboratory equipment is compliant with company and regulatory
• Drives, in conjunction with other departments and Company sites, the global application of compliance and operation.
• Directly supervises the Microbiology and Environmental Monitoring Supervisors. Carries out management responsibilities in accordance with the organization’s policies and applicable laws. Planning, assigning, and directing work, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Review new and revised regulatory and guidance documents and processes/practices to assure continuous improvement and compliance.

Bachelor’s Degree is required in Microbiology or Biology