QC Senior Analyst

PSC Biotech® Corporation; Leinster; On-site; EUR 42,000 - 62,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a QC Senior Analyst to join the QC team, focusing on testing and microbiology within cGMP environments. The role involves executing laboratory testing, supporting investigations, and ensuring data integrity to deliver compliant results for pharmaceutical clients.

Candidates should have a science/quality degree and 2-3 years in QC Microbiology, with experience in endotoxin, bioburden, water monitoring.

Qualifications

• Degree in Science/Quality/Technical field.
• Laboratory experience in biotech/pharma.
• 2-3 years in QC Microbiology.
• Knowledge of EM, Water Monitoring, Endotoxin Testing, Bioburden Testing.

Responsibilities

• Operate as part of the QC team performing testing and lab duties.
• Act as testing SME with QC; participate in OOS investigations.
• Participate in daily QC tier meetings; communicate testing progress and deviations.
• Write/revise/roll out procedures and training materials for Quality systems.
• Peer review of testing documentation; ensure data integrity and QC KPIs.
• Support lab readiness, audit readiness, and audit participation; equipment qualification; method transfer/validation.
• May be required to work 7 to 7 shift cycle.

Skills

QC Microbiology

Testing

Communication

Time management

Education

Science/Quality/Technical degree

Tools

Microsoft Office

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• The QC Senior Analyst works as directed by the QC Manager/QC Associate Director according to company safety policies, cGMP and cGLP. Ensure that QC team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
• Essential Functions and Responsibilities (Includes, but are not limited to) The QC Senior Analyst, is responsible for:
• Operating as part of the QC team performing the allocated testing and laboratory-based 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, deviations, escalation of potential cGMP or compliance issues etc.
• Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems.
• Peer review of testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Support activities including general lab readiness, audit readiness and audit participation, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Candidate might be required to go on shifts, yet to confirm. (It is 7 to 7 shift cycle)

Requirements

Responsibilities

• Contributing to a continuous improvement environment and bringing problem solving and troubleshooting capabilities.
• Demonstrating a commitment to learning and personal development

Minimum Education/Experience:

• Degree qualification (Science/Quality/Technical or related)
• Laboratory experience, including sampling, testing, reporting in the biotechnology and/or pharmaceutical industry.
• 2-3 years of experience in QC Microbiology
• Knowledge about EM, Water Monitoring, Endotoxin Testing, Bioburden Testing

General competencies:

• Motivation to be an inspiring member of a high performing team and passion to build the future
• Desire to continuously learn, improve and develop.
• Flexible and self-motivated.
• Required to work on their own initiative in addition to working as part of a team.
• Ability to manage multiple priorities and know when to escalates issues for resolution.
• Excellent time management and organizational skills.

Technical:

• 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.