Lead Microbiology Analyst - QC

Senior Lead Microbiology Analyst – QC role provides support to the start up and routine operations of the QC microbiology laboratory and works closely with the area technical lead and management. During start-up of the QC laboratories the role will be focused on developing E-systems, procedures and implementing test methods to support routine operations. This role will have oversight for the implementation and execution of the training programme for the QC microbiology analyst group. Furthermore, the role will focus on the implementation of data integrity requirements for microbiology laboratory equipment.

Key Responsibilities: QC Testing

• Safety: Safety first approach to activities.
• Method verification: Author and execute method verification protocols for microbiological test methods such as bioburden and endotoxin.
• Study support: Provide support for microbiological studies through protocol and report authoring; study execution; data review and data analysis.
• Equipment SME: Serve as equipment SME for microbiology lab test equipment. Compliance and Documentation:
• cGMP Compliance: Ensure all microbiological aspects of testing adhere to current Good Manufacturing Practices (cGMP). Ensure correct practices are in place in compliance with regulations, global standards and aligned with the site Data Management strategy.
• Data Review and Investigation: Lead microbiology laboratory investigations including alert and action limit excursions and deviations. Identify and implement corrective actions as needed.
• Documentation: Maintain accurate and detailed records. Author procedures, protocols, reports, investigations and change controls as required.
• Data integrity; Participate in data integrity assessments for area equipment and activities. Participate in and coordinate audit trail review process in collaboration with Quality Assurance/stakeholders.
• Inspection readiness: Support and participate in self-inspections or regulatory audits. Training and Process Improvement:
• Training and Leadership: Develop training material and lead training for new analysts within the microbiology team in techniques such as bioburden, endotoxin, growth promotion, environmental monitoring, microbial identifications, TOC, conductivity etc.
• Process Enhancements: Proactively identify opportunities for process improvements in the laboratory and support implementation. Benchmark best practices for analytical technology and implement appropriate improvements.
• Collaboration: Provide technical support to lab analysts and operations as required.

Basic Qualifications/Requirements:

• Bachelor’s degree in Microbiology, Biology, or related field.
• Minimum of 6 years of experience in microbiology testing within a pharmaceutical or biotechnology environment.

Job specific pre-requisites:

• Deep technical expertise in QC microbiology techniques.
• Significant level of cross training and demonstrated training ability on multiple microbiological techniques (e.g., aseptic technique, bioburden, endotoxin, growth promotion, environmental monitoring, and microbial identification).
• Good understanding of data integrity in the QC laboratory
• Good understanding of regulatory requirements for micro testing 
• Demonstrated excellent analytical technical, attention to detail and problem-solving skills. 
• Demonstrated expertise in a variety of microbiological techniques. 
• Demonstrated strong interpersonal skills. 
• Demonstrated strong verbal and written communication skills. 
• Demonstrated ability to participate in and facilitate decision-making. 
• Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel) as well as laboratory-based software (e.g. LIMS systems, electronic lab notebooks etc..). 
• Demonstrated good planning and organisational skills, ability to prioritise tasks, commitment to task completion and timelines. 
• Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set. 
• Coaching and mentoring capabilities 
• Proficient in English.