Job DescriptionJob ResponsibilitiesFunctions as the site Microbiology partner, in collaboration with other stakeholders, ensuring microbiology standards are enforced.
Coordinates the investigation and closure of deviations with effective root cause analysis.
Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented and monitored and effectiveness checks are completed.
Approves documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
Approves and delivers quarterly and annual environmental monitoring reports; Develops continuous improvement plans or actionable deliverables. Participates in the execution of quality system improvement programs and initiatives.
Perform monthly environmental data review.
Manage electronic MODA system.
Support insourcing projects and validations to meet timelines and ensure compliance.
Establishes Microbiology KPI Reporting and Metrics.
Establishes and maintains relevant process controls and data feedback systems to monitor the operation of the department.
Participates in internal audits, regulatory agencies, and client audits.
Qualifications:Bachelor of Science in biological sciences or other relevant field of study.
10-12 years' relevant microbiology experience in cGMP biotech and/or pharmaceutical environments. Experience in both clinical and commercial manufacturing is preferred.
Proficient in FDA and EMEA regulations and a working knowledge of root cause analysis.
Understanding of quality system applications, including the training, deviations, CAPA management, etc.
Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
Experience in organizing and leading teams.
Experience participating in health authority inspections and/or client audits.
CompetenciesHighly organized and capable of successfully managing multiple priorities using effective time management techniques
Proven ability to maintain accurate recordkeeping records
Written and oral communication skills in English; facilitate effective presentations
Must be accountable for work product and have a strong work ethic.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles:
Directly supervises 10 employees within the Microbiology department(s).
Indirectly supervises 20 employees within the Microbiology department(s).
Minimum Required Training (optional)
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility
Monday-Friday, 1st Shift