QC Technical Specialist II

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