Actalent
Microbiology Supervisor
Actalent, Allendale, New Jersey, us, 07401
Job Title: Microbiology SupervisorJob Description
We are seeking a dedicated Microbiology Supervisor to ensure compliance with regulatory agency requirements by fostering a quality culture throughout the department. You will manage daily operations based on client demands, conduct routine facility walkthroughs, approve investigations, and recommend process improvements for greater efficiency. You will also participate in department and cross-functional meetings, maintain audit readiness, and interact with internal and external customers to address questions and concerns.
Responsibilities
Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedule and monitor daily operations based on projected client demands.
Conduct routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approve investigations and documentation of non-conforming events and environmental excursions.
Recommend process improvements to achieve greater efficiency within the department and between sites.
Participate in department and cross-functional meetings.
Maintain audit readiness by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Determine staffing levels; recruit, interview, select, hire, and employ appropriate number of employees.
Provide oversight and direction to employees in accordance with the organization's policies and procedures.
Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.
Empower employees to take responsibility for their jobs and goals, delegate responsibilities, and hold staff accountable by providing regular feedback.
Foster teamwork and cohesiveness among department members and initiate conflict resolution when issues arise.
Create a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
Lead employees using performance management and development processes including goal setting, feedback, and performance development planning.
Appropriately communicate organization information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Essential Skills
Bachelor’s degree in Microbiology or a relevant field.
Minimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
Strong knowledge of FDA and EU regulatory standards.
Experience with cGMP.
Proficient with computer software including MS Office and LIMS (MODA experience preferred).
Strong knowledge of microbiological test methods and philosophies.
Strong knowledge of quality systems and ability to interpret quality standards of implementation and review.
Additional Skills & Qualifications
Experience with microbiology, environmental monitoring, aseptic technique, quality control, biology, bioburden, and cleanroom practices.
Experience managing a microbiology laboratory and familiarity with FDA regulations.
Ability to organize and direct staff to meet and exceed cGMP requirements.
Ability to establish KPIs while adhering to quality control-microbiological and technical standards.
Experience with SOPs and the pharmaceutical industry.
Work Environment
This role operates within a professional office environment of a manufacturing operations plant, using standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating includes a mix of open space, cubicles, and offices. The noise level is moderate. Exposure to gases (nitrogen), corrosive chemicals (Clorox, potassium hydroxide), and liquid nitrogen is possible. Proper personal protective equipment (PPE) must be utilized when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. You must be able to work in a team-oriented environment and handle specialized equipment. The shift for this role is Wednesday to Saturday (3:30 pm to 2 am) & Sunday to Wednesday (3:30 pm to 2 am).
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
We are seeking a dedicated Microbiology Supervisor to ensure compliance with regulatory agency requirements by fostering a quality culture throughout the department. You will manage daily operations based on client demands, conduct routine facility walkthroughs, approve investigations, and recommend process improvements for greater efficiency. You will also participate in department and cross-functional meetings, maintain audit readiness, and interact with internal and external customers to address questions and concerns.
Responsibilities
Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedule and monitor daily operations based on projected client demands.
Conduct routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approve investigations and documentation of non-conforming events and environmental excursions.
Recommend process improvements to achieve greater efficiency within the department and between sites.
Participate in department and cross-functional meetings.
Maintain audit readiness by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Determine staffing levels; recruit, interview, select, hire, and employ appropriate number of employees.
Provide oversight and direction to employees in accordance with the organization's policies and procedures.
Coach, mentor, and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities.
Empower employees to take responsibility for their jobs and goals, delegate responsibilities, and hold staff accountable by providing regular feedback.
Foster teamwork and cohesiveness among department members and initiate conflict resolution when issues arise.
Create a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
Lead employees using performance management and development processes including goal setting, feedback, and performance development planning.
Appropriately communicate organization information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Essential Skills
Bachelor’s degree in Microbiology or a relevant field.
Minimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
Strong knowledge of FDA and EU regulatory standards.
Experience with cGMP.
Proficient with computer software including MS Office and LIMS (MODA experience preferred).
Strong knowledge of microbiological test methods and philosophies.
Strong knowledge of quality systems and ability to interpret quality standards of implementation and review.
Additional Skills & Qualifications
Experience with microbiology, environmental monitoring, aseptic technique, quality control, biology, bioburden, and cleanroom practices.
Experience managing a microbiology laboratory and familiarity with FDA regulations.
Ability to organize and direct staff to meet and exceed cGMP requirements.
Ability to establish KPIs while adhering to quality control-microbiological and technical standards.
Experience with SOPs and the pharmaceutical industry.
Work Environment
This role operates within a professional office environment of a manufacturing operations plant, using standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating includes a mix of open space, cubicles, and offices. The noise level is moderate. Exposure to gases (nitrogen), corrosive chemicals (Clorox, potassium hydroxide), and liquid nitrogen is possible. Proper personal protective equipment (PPE) must be utilized when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. You must be able to work in a team-oriented environment and handle specialized equipment. The shift for this role is Wednesday to Saturday (3:30 pm to 2 am) & Sunday to Wednesday (3:30 pm to 2 am).
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.