Testing, processes, methods, and validation exercises conform to internal procedures, reflect applicable regulations/guidelines, and meet industry best practices. Your key duties and responsibilities include:
* Working within a controlled ISO 13485 laboratory quality system and in accordance with GLP/GMP compliant procedures.
* Supervising a team of 3-6 microbiology staff.
* Ensuring microbiology lab staff are trained and proficient at their tasks and follow established standard procedures.
* Conducting General Laboratory Compliance Awareness training for new starters; ensuring lab compliance with cGMP regulations and SOPs.
* Managing the daily technical operations of the microbiology laboratory.
* Overseeing the laboratory testing schedule and ensuring all microbiological testing, processes, methods, and validation exercises conform to internal procedures, reflect regulations, and meet industry standards.
* Prioritizing tasks to meet testing deadlines.
* Representing the Microbiology Lab on various teams as a functional lead.
* Deputizing for the laboratory manager when absent; representing the microbiology laboratory during audits.
* Troubleshooting issues, managing deficiencies, OOS, non-conformances, and failures related to equipment, procedures, and test methods.
* Ensuring all laboratory instruments and equipment are calibrated per regulatory requirements and schedules.
* Ensuring microbiology equipment is fully qualified (IQ/OQ/PQ) and supporting software validation activities.
* Performing detailed investigations into atypical and out-of-spec results, applying corrective actions, and reporting findings.
* Writing COSHH and risk assessments for laboratory procedures.
* Having 5+ years of microbiology laboratory experience.
* Possessing working knowledge of FDA and European regulations related to Quality Systems (ISO 13485:2016, ISO 9001:2015, FDA 21 CFR part 820 or equivalent), GMP, and GDP.
* Experience with microbiology-related pharmacopeial/ISO standards.
* Supervising staff in a laboratory setting.
* Background in microbiology with proven experience and knowledge in the field.
* Excellent analytical, problem-solving, and data interpretation skills.
* Strong SOP, investigation, protocol, and technical report writing skills.
* Proficiency in Microsoft Office.
* Effective communication skills and ability to work in cross-functional teams.
* Highly motivated, flexible, and team-oriented.
Qualifications/Education:
* Degree in Microbiology, Biology, or a related discipline.
* Knowledge of FDA and European Quality System regulations (desirable: ISO 13485:2016, FDA 21 CFR part 820).
* Good knowledge of Microsoft Word and Excel.
About Convatec:
Pioneering trusted medical solutions to improve lives. A global leader in medical products, with over 10,000 employees across 90 countries. In 2024, revenues exceeded $2 billion. For more information, visit Convatec.
Role Details:
Team Lead - Laboratory Services overseeing daily operations, supervising staff, and managing testing schedules. Location may be in Deeside with onsite work.
Environment:
Laboratory/Office setting with exposure to biological agents, chemicals, and reagents.
Special Factors:
Exposure to Hazard Group 1 and 2 biological agents.
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