Microbiology Operations Manager

Responsible for all activities in the microbiology laboratory, working closely with the Site Director, Microbiology staff, Quality Manager, Business Development and customers. Is a member of the Quality Committee and can act as a Business Unit Leader or Quality Manager in his/her absence. Ensures compliance of the testing within the microbiology laboratory with cGMP, ISO 17025 and company quality standards.
Essential Duties/ Responsibilities:
Provides operational leadership and support through effective planning,
execution, management of personnel and available resources.
Motivates staff to perform at high levels, and ensures engaged employees, satisfied clients, and efficient processes that are quality driven.
Assist the Business Unit Manager in managing daily operations of the microbiology laboratory including scheduling, supervising, instructing, monitoring, and assisting in the performance of manual and instrumental analyses. Develops and maintains production schedules, ensuring on-time completion and delivery of Reports and Data Packages into QA.
Is a subject matter expert for the business in their field. Provides and assists customers with understanding regulatory guidelines, test results, technical support, and the appropriateness of specific tests, including advantages and limitations of test procedures.
Accomplished productivity through effective communication of company
goals/objectives and supports staff in achieving such expectations by
appraising performance and giving continuous feedback.
Plans and oversees development of new laboratory technologies and test
methods.
Ensures continuous development and training of staff.
Ensures that the facility, instrumentation, and equipment are well maintained
and in good working order.
Ensures the implementation of the laboratory Quality Management System
and its compliance with ISO/IEC 17025.
Handles client and employee requests and concerns appropriate and in a
timely manner.
Performs laboratory testing, when necessary.
Evaluates resumes, interviews potential employees, and hires new personnel.
Assists in writing regulatory documents relating to the Quality Management System and regulatory agencies such as ISO, AAMI, USP, and FDA.
Education:
Bachelor’s degree in microbiology, or a related field.
Experience:
Minimum of 2-3 years of experience in a testing laboratory, with a preference given to candidates with supervisory experience
Good knowledge of quality systems such as ISO 17025 and cGMP.
Internal contact includes daily contact with all personnel and regular contact with management.
External contact may require infrequent contact with Clients.
External contact with vendors may be required.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Competencies:
Detailed understanding of microbiological sciences related to pharmaceutical and medical device testing.
Excellent verbal and written communication skills.
Excellent interpersonal and organizational skills.
Responsive problem solver and action-oriented

Employment type
Full-time

Work arrangement
No