Title: Quality Control Supervisor

Location: Allendale, NJ

Duration: Full Time

Shift: Sunday - Wednesday (3:30 pm to 2 am)

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.

• Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Schedules and monitors daily operation of department based on projected client demands.
• Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Approval of investigations and documentation of non-confirming events and environmental excursions.
• Recommends process improvements to achieve greater efficiency within the department and between sites.
• Participates in department and cross functional meetings.
• Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
• Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a Microbiology or relevant field
• Minimum of 7+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
• Minimum of 2 years of experience in a supervisory or lead role.
• Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
• Strong knowledge of microbiological test methods and philosophies.
• Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
• Proficient with computer software with MS Office and LIMS (MODA experience preferred).