Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Reporting Structure:

Reports to: Team Leader, QC Equipment Calibration

Function: Quality (Quality Control)

Position Purpose:

The QC Equipment Calibration and Lab Support Specialist is responsible for ensuring the lifecycle management, qualification, calibration, compliance, and operational support of laboratory analytical instruments and associated computerized systems within the QC environment.

The role operates in compliance with company SOPs, GMP/GLP requirements, Data Integrity principles, and applicable regulatory standards. The position supports both technical and organizational aspects of laboratory instrumentation, including implementation of new equipment, system management, documentation oversight, vendor coordination, and continuous improvement initiatives.

Key Responsibilities:

Laboratory Equipment & Systems Lifecycle Management:

• Manage activities related to installation, relocation, upgrade, and decommissioning of analytical instruments and associated computerized systems.
• Support the preparation of URS (User Requirement Specifications), vendor evaluation, GMP impact assessments, and Change Control management.
• Coordinate and supervise external service providers and technical vendors.
• Support evaluation for purchase, replacement, or obsolescence of laboratory equipment.

Calibration, Qualification & Compliance

• Ensure instruments remain in a qualified and calibrated state according to SOPs, GMP requirements, and regulatory guidelines.
• Contribute to internal and external qualification protocols and reports.
• Support proper management of analytical software systems in compliance with Data Integrity and IT security requirements.
• Ensure correct documentation management within Track Wise and other quality systems.

Documentation & Quality Systems:

• Draft, review, update, and archive SOPs, qualification documentation, protocols, and reports.
• Ensure compliance with company Quality Policies and continuous monitoring of KPIs.
• Contribute to On-Time Delivery (OTD) and Right First Time (RFT) targets.

Operational Support & Cross-Functional Collaboration:

• Act as technical interface between QC laboratories and stakeholders.
• Collaborate with Finance and Technical functions for equipment introduction and costs control.
• Ensure alignment of activities with project timelines and business unit expectations.
• Provide structured updates to management on project and operational progress.

REQUIREMENTS:

Education:

• High School Diploma in Chemistry or IT-related field, or
• Bachelor's Degree in Chemistry, Pharmaceutical Chemistry (CTF), or equivalent scientific discipline

Technical Knowledge:

• Strong knowledge of analytical techniques and laboratory instrumentation
• Solid understanding of GMP/GLP regulations
• Familiarity with laboratory software systems and data management systems
• Knowledge of quality systems and change control processes
• Understanding of computerized system validation (CSV) principles is a plus

Professional Experience:

• Experience in QC laboratories within pharmaceutical or chemical industries, or
• Experience with laboratory equipment suppliers
• Experience in FDA-regulated environments is desirable
• Previous experience in multinational pharmaceutical companies is a plus

Languages:

• Good command of English (written and spoken)

Personal Competencies:

• Strong organizational and planning skills
• High attention to detail and accuracy
• Team-oriented mindset
• Effective communication skills
• Ability to manage multiple priorities and projects
• Problem-solving and proactive approach

Physical Requirements / Work Environment:

(Provide details)

What We Offer:

Compensation:

• Competitive pay
• Performance-related bonus where applicabl

Excellent Benefits:

• Medical benefits
• Paid Time Off/Annual Leave
• Employee Referral Bonus
• Career Advancement Opportunities