Supervisor, QC Microbiology – Allendale, NJ
Our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
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: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.
- Perform microbiological and environmental monitoring data review. Compile and issue quarterly and annual Environmental monitoring trending reports.
- 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.
- Author and revise Standard Operating Procedures, Work Instructions, forms and protocols to reflect current practices
- 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.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws
- Other duties as assigned.
- Qualifications:Bachelor’s degree in a Microbiology or relevant field
- Minimum of 5+ years of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
- Minimum of 1 year 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).
