Job Title: QC Microbiology Manager
Job Description

The QC Microbiology Manager ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department. This role schedules and monitors the daily operation of the department based on projected client demands, and conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices. You will be responsible for the approval of investigations and documentation of non-conforming events and environmental excursions, recommending process improvements, and participating in department and cross-functional meetings. Maintaining audit readiness, interacting with internal and external customers, and performing other assigned duties are also key aspects of this role.

ResponsibilitiesEnsure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.Schedule and monitor daily operation of the department 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 within the department 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 responsibility and hold staff accountable by providing regular feedback.Foster teamwork and cohesiveness among department members; expeditiously 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 a performance management and development process to include goal setting, feedback, and performance development planning.Appropriately communicate organization information through department meetings, one-on-one meetings, appropriate emails, and regular interpersonal communication.Essential SkillsStrong knowledge of FDA and EU regulatory standards.Minimum of 8+ years of experience with environmental monitoring or within the biopharmaceutical industry.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.cGMP experience required.Additional Skills & QualificationsBachelor’s degree in Microbiology or a relevant field.Work Environment

This role operates within a professional office environment of a manufacturing operations plant. You may be exposed to gases (nitrogen) or corrosive chemicals (Clorox, potassium hydroxide), and liquid nitrogen. The noise level is moderate. Proper personal protective equipment (PPE) must be utilized when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. You must have the ability to observe staff in a cleanroom environment for a period of time and work with specialized equipment. The work environment includes a mix of open space seating, cubicles, and office space. Standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines are routinely used.

Pay and Benefits

The pay range for this position is $66.00 - $68.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Allendale,NJ.

Application Deadline

This position will be accepting applications until Jan 17, 2025.

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 for other accommodation options.