Essential Functions:
• Provide technical and compliance leadership to business processes within QC Microbiology scope of responsibilities. Collaborate cross-functionally in the site early-stage activities, including identification and review of user requirements; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up and selected electronic Quality Systems for operation (LIMS/ELN/LES).
• Advance knowledge and experience qualifying, transferring, and performing compendial and non-routine microbiological methods and procedures following the established policies, Standard Operating Procedures, Analytical Methods, and Specifications in a GxP environment. Examples: Bioburden (TAMC/TYMC), Bacterial Endotoxins (LAL), Growth Promotion, Microbial Identification, rapid microbiological methods, among others.
• Expertise on Sampling, Culturing, Microscopy, and Aseptic Techniques.
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures as applicable to stand up the QC Microbiology operations and develop GxP training requirements for QC Staff.
• Establish a Site Risk Management procedure seeking to ensure a consistently robust and compliant methodology is implemented for the documentation of risk-based approaches and decisions based on sound rationales, with justifications supported by facts and data.
• Lead and coordinate cross-functionally the robust and compliant and timely implementation of the required Site GxP procedures in support of the Environmental and Utility Monitoring Program and Contamination Control Strategy.
• Design and implement a site procedure for the investigation of Objectionable Microorganism.
• Leverage technical expertise to train and qualify team member members in the correct execution of Microbiology-related methods on a variety of sample types (e.g., Validation samples, Water, Air, Gases, Raw Materials, Surfaces, In-process, DS release, Stability, investigation, among others).
• Provide technical leadership to the facility and utility Environmental Monitoring Performance Qualification (EMPQ), to ensure facility readiness and to achieve production targets compliantly.
• Review and approve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Ensure compliance with current regulatory requirements for Data Integrity (ALCOA++) requirements as applicable to paper and electronic records (21 CFR Part 11).
• Provide assistance to the Senior Manager of QC by onboarding, training, leading, and mentoring junior QC Microbiologists, cross-functional staff and/or contractors in QC Microbiology topics, as needed, per approved staffing plans.
• Coordinate, schedule, and assign sampling and testing tasks. Review and approve QC Laboratory results.
• Establish key operational processes within the QC Microbiology Lab including: Laboratory gowning requirements, personnel and materials flow; sample receipt, processing, and disposal; Inventory management (i.e., ordering, receive, qualification, and release of critical lab supplies and consumables; Laboratory safety, Laboratory Waste management and disposal, Laboratory cleaning).
• Prepare laboratory reports and communicate results and findings to key stakeholders (e.g., Microbial Trends Report, EM/UM recoveries and excursion reports, OOS, Invalid Assays, among others).
• Collaborate cross-functionally with the Operations and Quality Teams on ensuring alignment to global, regional policies and procedures.
• Collaborate with Quality Assurance and Quality Systems and Compliance in inspection readiness efforts and responding to compliance requests, findings, or concerns.
• Lead and ensure timely investigation of non-conformances, deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for diligent and effective resolution.
• Establish key performance indicators for Site Quality Metrics including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM Data trends, Stability Trends, Product Disposition Cycle-times, among others).
• Provide subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
• Develop, approve, monitor, and communicate progress against goals cross-functionally and to Site Leadership Team, and key stakeholders.
N/A