Senior QC Analyst

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Job Description

JOB DESCRIPTION

JOB TITLE:                          Senior Testing Analyst

REPORTS TO:                     Team Leader, Quality Control

 

JOB PURPOSE:

 

The purpose of this role is to elevate the quality, predictability and effectiveness of laboratory testing activities by providing senior-level technical oversight, coordination and decision support beyond day-to-day test execution.

 

This position serves as the senior technical and operational resource within the testing group, bridging the gap between laboratory execution and Team Leader responsibilities while maintaining a strong hands-on involvement in testing activities.

 

This role requires a thorough knowledge of Good Manufacturing Practice, laboratory operations, testing processes and quality systems. The role demands strong analytical judgement, leadership capability and a commitment to driving Right First Time (RFT) performance while ensuring testing activities are executed efficiently, compliantly and in alignment with business priorities.

 

The Senior Testing Analyst is responsible for improving testing effectiveness and decision making through technical leadership, risk-based thinking, mentoring and continuous improvement. The incumbent serves as a key resource for resolving complex issues, maintaining operational continuity and supporting the Team Leader in delivering departmental objectives.

 

RESPONSIBILITIES:

• To observe Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) at all times.
• Perform testing activities across assigned laboratory scope in accordance with approved procedures, specifications and pharmacopoeial requirements.
• Review testing activities to ensure laboratory priorities are maintained and delivery commitments achieved.
• Effectively manage designated non-testing laboratory programmes and associated departmental processes.
• Coordinate testing activities to ensure appropriate workload balance, coverage, compliance and delivery performance across the team.
• Lead resolution of complex, ambiguous or cross-functional issues which may impact testing schedules, laboratory compliance or product disposition.
• Provide day-to-day guidance to analysts regarding testing approach, prioritisation, troubleshooting and problem resolution.
• Drive Right First Time (RFT) performance through coaching, mentoring and reinforcement of quality expectations.
• Review laboratory data and documentation to ensure accuracy, completeness and compliance with approved procedures.
• Support assessment of testing risks, testing scope and release readiness, providing experienced judgement when the Team Leader is unavailable.
• Participate in and support laboratory investigations, root cause analysis activities and implementation of effective corrective and preventive actions.
• Validation, operation, maintenance, calibration and troubleshooting of laboratory instrumentation as required.
• Lead, facilitate and participate in continuous improvement initiatives to enhance laboratory efficiency, compliance and effectiveness.
• Identify opportunities for process simplification, error reduction and operational excellence.
• Support implementation and sustainability of 5S and laboratory housekeeping standards.
• Assist in preparation, review and revision of laboratory procedures, protocols, reports and associated documentation.
• Support training activities and ensure knowledge transfer across the laboratory team.
• Act as delegate for the QC Laboratory Team Leader as required.
• Ensure the laboratory is maintained in a clean, safe and inspection-ready condition at all times.

GENERAL RESPONSIBILITIES:

 

• Participate fully in cross-functional training initiatives and departmental improvement programmes.
• Mentor and coach members of the Quality Control organisation.
• Promote a culture of quality, compliance, accountability and continuous improvement within the workplace.
• Foster an environment of safety awareness where safety is recognised as an integral component of all laboratory activities.
• Ensure Accident Reports, Near Miss Reports and Safety Observations are completed and addressed in a timely manner.
• Ensure timely completion of all SOP reading, training curricula and competency assessments.
• Support internal audits, customer audits and regulatory inspections as required.
• Support departmental objectives and strategic initiatives as assigned by management.
• Undertake other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:  

 

• BSc (minimum) in a scientific discipline or related field.
• Additional qualifications in laboratory sciences, quality systems, operational excellence or project management would be advantageous.

RELEVANT EXPERIENCE:

 

·         Relevant experience within a GMP-regulated pharmaceutical or biotechnology environment.

·         Minimum 4 years laboratory testing experience.

·         Demonstrated experience in troubleshooting, problem solving and investigation activities.

·         Experience coordinating laboratory activities and supporting operational decision-making.

·         Experience mentoring, coaching or training laboratory personnel.

·         Proven track record of contributing to continuous improvement initiatives.

·         Advanced knowledge of GMP, GLP and laboratory quality systems.

SKILLS/COMPETENCIES:

 

• Self-starter who is motivated, proactive and innovative.
• Strong analytical thinking and problem-solving capability.
• Demonstrated ability to influence and guide others without direct managerial authority.
• Excellent organisational, communication, interpersonal and technical writing skills.
• Ability to assess risk and make sound decisions using available data and experience.
• Ability to coordinate multiple priorities while maintaining compliance and delivery expectations.
• Strong coaching and mentoring capability.
• Ability to promote teamwork through a supportive and inclusive team environment.
• Ability to adapt effectively to changing priorities and business needs.
• Commitment to continuous improvement and operational excellence.
• Provide team members with, constructive feedback, coaching and support to help them recognize and on their strengths and development needs.
• Good investigational and technical writing skills.
• Be a self starter who is willing to learn.
• Strong Interpersonal & communication skills.
• Problem solving capability.
• Good organisational skills.

Locations

Bray, Ireland

Base Salary Range:

€41,400.00 - €56,870.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time