QC Analyst

PSC Biotech Corporation; Leinster; On-site; EUR 32,000 - 46,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a QC Analyst with 1-3 years of laboratory experience to join our quality team. You will perform testing and lab-based duties, ensuring data integrity and compliance with cGMP and GLP.

Based in Dundalk, Co. Louth, the role offers exposure to top pharmaceutical client sites and opportunities for career development through in-house training and mentorship.

Qualifications

• 2 years of laboratory experience, including sampling, testing, reporting.
• Knowledge of cGMP, GLP, and Quality Management Systems.
• Strong communication and problem-solving skills.
• Proficiency with IT and MS Office.

Responsibilities

• Operate as part of the QC team performing the allocated testing and laboratory duties.
• Act as testing SME with QC department, participate in OOS investigations and supporting troubleshooting activities.
• Participate in QC Tier daily meetings and ensure effective communication of testing progress.
• Write/revise/roll out accurate SOPs and training materials for quality systems.
• Peer review of testing documentation and ensuring data integrity and KPIs.
• Support activities including lab readiness, audits, and equipment qualification.

Skills

Motivation

Lifelong learning

Flexible

Communication

IT skills

Critical thinking

cGMP knowledge

GLP knowledge

QMS knowledge

Tools

Microsoft Office

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 1-3 years
• City Dundalk
• State/Province Louth
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Position Overview:

• The QC analyst works as directed by the QC Manager/QCAssociate Director according to company safety policies, cGMP and cGLP. Ensurethat QC team objectives are effectively achieved, consistent with requirements to ensure compliance, safety andreliable supply to our customers.

Requirements

Responsibilities:

• Operate as part of the QC team performing the allocatedtesting and laboratory-based duties.
• Act as testing SME with QC department, participate in OOSinvestigations and supporting troubleshooting activities.
• Participate in QC Tier daily meetings and ensureeffective communication of testing progress, deviations, escalation ofpotential cGMP or compliance issues etc.
• Participate in writing/revising/ rolling out accurateoperational procedures, training materials and maintenance procedures forvarious Quality systems.
• Peer review of testing documentation and ensuring dataintegrity compliance and QC Right First Time KPIs are achieved.
• Support activities including general lab readiness, auditreadiness and audit participation, laboratory equipment qualification andanalytical method technical transfer, verification and validation.
• Maintain laboratory equipment, cleaning and supportvendor maintenance tasks.
• Carry out and execute CMMS tasks in conjunction withequipment maintenance
• Contributing to a continuous improvement environment andbringing problem solving and troubleshooting capabilities.
• Demonstrating a commitment to learning and personaldevelopment.

Qualification

• 2 years of laboratory experience, including sampling,testing, reporting.

Skills Requirements

• Motivation to be an inspiring member of a high performingteam and passion to build the future of
• Desire to continuously learn, improve and develop.
• Flexible and self-motivated.
• Possess effective communication and presentation skills.
• Proficient with IT e.g. Microsoft office.
• Good critical thinking and problem solving skills.
• Good knowledge of cGMP, GLP, Quality Management Systems.