Sr QC Microbiology Manager

Proclinical is seeking a Senior QC Microbiology Manager located in King of Prussia, PA with a leading biotech and biopharmaceutical company. This position proactively drives change and improvement to the microbiology lab, while establishing a culture of compliance through implementation of harmonized standards, testing, monitoring, and reporting.

Job Responsibility:

• Maintain the Microbiology Lab and function in full cGMP-compliance and continue to challenge the status quo of the labs to enhance throughput efficiency and Compliance while ensuring Method lifecycle management.
• Responsible to oversee installation of laboratory equipment and qualification/validation of lab equipment for intended use in QC laboratory to support testing (e.g., Mycoplasma detection, Bioburden, Endotoxin, Sterility Testing, CCIT and Sub Visible particulate)
• Ensure proper oversight and management for protocol development, report writing, trend report and deviation management
• Ensure that priorities (lab scheduling, logistics and flow of activities) for testing and review are set and followed
• Ensure proper scheduling and prioritization of workload and staff to ensure all activities are performed.
• Lead laboratory investigations and facilitates root cause analysis
• Reviews documents to ensure completeness, accuracy, consistency, and clarity and ensure that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs
• Ensure programs for trending are in place including assessment for CAPAs based on trend conclusions
• Collaborate with Manufacturing, Supply Chain and Logistics and Quality to ensure an
• uninterrupted supply of materials for use in Manufacturing
• Participate in audits (internal / external) where necessary (prep, support, interactions) internal/external audit program
• Participate in the preparation and consolidation of the budget of the Quality Unit
• Identify and implement improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes
• Collaborate significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs
• Act as Microbial testing SME during regulatory and client audits.
• Act as technical expertise during client meetings.
• Manage a team of Senior Microbiologists in the Quality Control department
• Oversees the microbiological testing for raw materials, in-process materials, intermediates, and final product
• Read, trend, and report in-process, raw material, finish product and water bioburden testing results
• Oversee Lab Investigations
• Implement new technology to increase efficiency

Skills and Requirements:

• Delivery of results in time and quality (e.g., review and approve validation, qualification protocols and reports)
• Complete and ensure projects are progressing according to plan and quality expectations.
• Ensure there is a limited number of gaps identified during external and internal audits and in the same context, none of the issues identified are severe / critical
• No critical observations during authority inspections
• No delay with new product introductions caused by the lab
• Support implementation of programs such as but not limited to Labware.
• Ensure programs are in place for trending which includes determination of alert and action limits and systems in place to act accordingly
• Education: BS in microbiology or closely related field with 7 years' experience in a microbiology lab, preferably in the pharmaceutical or biotech industry; with 3-5 years of that experience in a leadership role in the microbiology lab
• Ability to maintain integrity and honesty, and always communicate with transparency
• Continuously drive to improve process for improved performance
• Ability to lead and be accountable for team's performance and results
• Manage internal and external relationships
• Develop strategy and create metrics to measure effectiveness of strategy
• Provide leadership to direct and indirect reports

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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