JOB TITLE
Laboratory Manager
DEPARTMENT
Quality
REPORTING TO
Head of Quality
Individual Contributor or People Manager
People Manager
OBJECTIVES OF POSITION
Provide final review and approval of results, protocols, reports, SOP's etc.
To act as the primary laboratory point person accountable for the team achieving a continually high standard of work.
This role functions as a Subject Matter Expert (SME) to coordinate scheduling, deliver compliant products on time, and create a work environment that supports team effectiveness through coaching and mentoring.
RESPONSIBILITIES
Maintain regulatory compliance through established programs for lab testing, environmental control, training, SOP's, technical investigations, test method validation and cleaning in a medical device regulated environment.
Develop and maintain quality systems within the laboratory to ensure ongoing compliance to cGMP
Compliance with Standard Operating Procedures and Registered specifications.
Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
Issue trend reports on investigations, non-conformances.
Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations.
Approval of SOP's, trend data, investigations, deviations, validation protocols, reports, method validation/verifications and equipment qualifications.
Participate in regulatory agency inspections.
Plan and implement procedures and systems to maximise operating efficiency.
Manage and contribute to the achievements of department productivity and quality goals.
Manage the scheduling and control of product testing to ensure output targets are achieved.
Review and authorize records for product disposition in accordance with cGMP and defined procedures.
Coordinate testing and analysis of batches to meet customer expectations.
Oversee and sign off on out-of-specification investigations.
Act as the primary point of contact and SME for audits and inspections.
Monitor and assist hands-on in daily laboratory activities.
Ensure the laboratory is maintained in a clean, audit-ready condition with sufficient consumables.
Liaise with the Department Manager regarding recruitment and resource planning.
Ad hoc duties as assigned by area Manager
Quality
Assure ongoing compliance with quality and industry regulatory requirements
Proactively prevent or reduce non-conformances and support CAPA/change control processes.
Ensure local quality requirements are considered for new or changed laboratory methods.
Health & Safety
Ensure compliance with Health & Safety Legislation and Regulations.
Generate and maintain risk assessments for the laboratory area.
Promote safety awareness and proactively reduce hazards and risks within the lab.
MEASUREMENTS
Achievement of output targets and delivery of quality products on time.
Audit readiness and successful outcomes of quality/compliance inspections.
PERSONNEL SPECIFICATIONS
Qualifications and Experience
NFQ Level 8 Degree in Microbiology or associated Life Science discipline.
5+ years microbiology work experience, ideally the majority of which in a FDA regulated environment.
2 years team lead / people management experience in microbiology testing within the laboratory is required, including conducting performance reviews.
Experienced in lead the training & development of micro analysts.
Experienced in the calibration and use of laboratory instrumentation, including troubleshooting equipment when problems arise.
Excellent communication and presentation skills.
Minimum 1 year of experience in a product testing environment with analytical instruments.
Previous supervisory or leadership experience is preferred to lead and develop a team in a regulated environment.
Experience running and maintaining a laboratory to GLP standards is preferred.
Working knowledge of cGMP, EHS, and applicable regulatory standards.
Core Competencies
High attention to detail, ensures accuracy in testing and documentation.
Strong organizational and practical skills with the ability to manage changing priorities.
Proactive and accountable mindset regarding quality, efficiency, and safety.
Strong communication and interpersonal skills for stakeholder alignment and handovers.
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