QC Technical Specialist II

ThermoFisher Scientific; Singapore; On-site; SGD 60,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific in Singapore invites an Engineer/Scientist II, QC to perform testing and data analysis in a GMP environment. You will handle raw materials, in-process samples and finished products using state-of-the-art analytical equipment to ensure product quality.

Prepare qualification protocols and reports, participate in continuous improvement, and collaborate with lab personnel, IT and vendors to maintain calibrated systems and meet regulatory expectations.

Qualifications

• Bachelor's degree in a relevant scientific field with 3–5 years of experience
• Strong knowledge of GMP regulations and quality systems requirements
• Proficiency in analytical systems including LIMS, CDS, HPLC, GC, UV, IR
• Knowledge of regulatory standards (ISO, FDA, USP, EP)
• Ability to work independently and meet critical timelines
• Excellent written and verbal communication in English
• Experience with laboratory automation systems preferred

Responsibilities

• Lead and deploy lab system projects as site SME (CDS/LIMS) to meet timelines and deliverables
• Lead, perform and support qualification of new equipment and lab systems according to regulatory expectations
• Prepare technical documentation including qualification protocols and reports
• Collaborate with stakeholders to ensure QC lab facilities, utilities, systems and equipment are maintained and calibrated
• Ensure equipment maintenance and calibration are scheduled timely and compliant
• Support lab investigations related to lab systems and equipment as SME
• Coach colleagues with knowledge of lab systems and equipment
• Participate in Practical Process Improvement initiatives (PPI) and continuous improvement
• Promote a Quality Culture and 5S mindset in QC
• Ensure cGMP compliance across the business
• Contribute to site audits for regulatory readiness

Skills

English communication

Attention to detail

Time management

Independent work

Team collaboration

Education

Bachelor's Degree in Science

Tools

LIMS

CDS

HPLC

GC

UV

IR

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

DESCRIPTION:

Join our Quality Control team at Thermo Fisher Scientific where you'll make meaningful contributions to our mission of enabling customers to make the world healthier, cleaner and safer. As an Engineer/Scientist II, QC, you'll perform testing and analysis to ensure product quality while working with state-of-the-art analytical equipment in a GMP environment. You'll conduct testing of raw materials, in-process samples, and finished products using various analytical techniques, evaluate test data, document results, and participate in continuous improvement initiatives. This role offers excellent opportunities for professional growth while working alongside colleagues who share your commitment to science and quality.

RESPONSIBILITIES :

• Lead and deploy lab system projects as site SME, e.g. Chromatography Data System -Chromeleon/Empower (CDS), Laboratory Information Management System (LIMS) to meet timelines and deliverables.
• Lead, perform and support qualification of new equipment and lab systems according to regulatory expectations and in compliance with FDA 21 CFR Part 11 compliance.
• Prepare technical documentation including but not limited to qualification protocols and reports, periodic review reports, standard operating procedures and investigations.
• Work collaboratively with all stakeholders (e.g. lab personnel, global lab solution team, IT and vendors) to ensure QC lab facilities, utilities, system and equipment are maintained and calibrated in accordance to regulatory expectations
• Ensure that equipment maintenance and calibration are scheduled timely, performed and reviewed for accuracy, completeness and in compliance with regulatory expectations and documented procedures.
• Support lab investigation related to lab system and equipment as SME.
• Coach colleagues with knowledge of lab system and equipment.
• Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
• Support and encourage a "Quality Culture" and company 4i values throughout QC
• Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.
• Work compliantly and adopt EHS, cGMP and 5S mindset.
• Undertake ad-hoc activities that may be required by business.
• Participate and support in the preparation of site audits, customer audits and regulatory audits to ensure GxP and regulatory compliance.

EH&S:

• Understand emergency procedures and adhere to safe systems of work.
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

Minimum Requirements/Qualifications:

• Bachelor's Degree with at least 3 to 5 years of relevant industrial experience (preferably in the pharmaceutical or medical devices industry)
• Preferred Fields of Study: Chemistry, Biochemistry, Biology, Molecular Biology or related scientific field
• Strong knowledge of GMP regulations and quality systems requirements
• Proficiency in analytical systems including LIMS, CDS, HPLC, GC spectrophotometry, UV, IR, etc.
• Good knowledge of LIMS, CDS, analytical equipment capabilities and operational needs
• Knowledge of relevant regulatory standards (ISO, FDA, USP, EP)
• Ability to work independently and adhere to critical timelines
• Excellent attention to detail and ability to follow written/verbal procedures accurately
• Strong organisational and time management skills
• Ability to work both independently and collaboratively in a team environment
• Proficiency in Microsoft Office applications
• Clear written and verbal communication skills in English
• Experience with laboratory automation systems preferred

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.