Job Overview:

The Supervisor, QC Microbiology will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control-microbiological and technical standards. The QC Environmental Monitoring Supervisor will also provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.

Essential Functions and Responsibilities:

 

Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

 

•\tEnsures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

•\tSchedules and monitors daily operation of department based on projected client demands.

•\tConducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.

•\tApproval of investigations and documentation of non-confirming events and environmental excursions.

•\tRecommends process improvements to achieve greater efficiency within the department and between sites.

•\tParticipates in department and cross functional meetings.

•\tMaintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.

•\tInteracts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.

•\tOther duties as assigned.

Qualifications:

•\tBachelor’s degree in a Microbiology or relevant field

•\tMinimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.

•\tMinimum of 2 years of experience in a supervisory or lead role.

•\tStrong knowledge of FDA and EU regulatory standards. cGMP experience required.

•\tStrong knowledge of microbiological test methods and philosophies.

•\tStrong knowledge of quality systems and ability to interpret Quality standards of implementation and review.

•\tProficient with computer software with MS Office and LIMS (MODA experience preferred).

Supervisory Responsibility:

•\tDetermines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.

•\tProvides oversight and direction to the employees in accordance with the organization's policies and procedures.

•\tCoaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.

•\tEmpowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.

•\tFosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise. 

•\tCreates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.

•\tLeads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.

•\tAppropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.

 

Quality Requirements:

•\tBuild Quality into all aspects of your work by maintaining compliance to all quality requirements.

•\tEnsure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).

•\tAttend all required Quality & Compliance training at the specified interval.

 

Direct Reports: QC Microbiology Analysts

 

Minimum Required Training to be Completed within the First 90 Days of Hire

•\tGxP/GDP Training as assigned

•\tEHS Safety Training

 

Aseptic Processing Standards:

•\tThe employee must be able to comply with the company’s personal hygiene standards as they apply to aseptic processing. 

•\tThe employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. 

 

Working Environment

 

•\tWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.  

•\tOther exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the c work environment is moderately noise.

•\tMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

•\tMust have the ability to observe staff in a cleanroom environment for a period of time.

•\tMust be able to work in a team-oriented environment.

•\tMust have the ability to work with specialized equipment.

•\tThis role operates within a professional office environment of a manufacturing operations plant. 

•\tThis role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate. 

Pay and Benefits

The pay range for this position is $52.00 - $52.00/hr.

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 is anticipated to close on Mar 6, 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.