Allendale, NJ, 07401, USA
15 hours ago
Supervisor, QC Microbiology
Urgently hiring an Quality Control Analyst for a growing CDMO cell and gene therapy company! Position Summary: The QC Environmental Monitoring Supervisor 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. Job Description: + 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 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. + 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). 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.
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