Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

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:
Be part of our Quality Control team at Thermo Fisher Scientific, where you'll contribute by ensuring the quality and reliability of products that help make the world healthier, cleaner and safer. You'll perform testing and analysis to support the development of innovative therapeutic products. You'll conduct quality control testing of raw materials, in-process samples, and finished products using various analytical techniques. You'll document and analyze test results, participate in investigations, and contribute to continuous improvement initiatives. This role offers opportunities for professional growth while working with skilled colleagues who share our commitment to excellence and innovation.

Laboratory Testing & cGMP Compliance

*   Perform accurate and precise QC testing on a variety of samples including raw materials, incoming goods, in-process intermediates, and finished products in strict compliance with current Good Manufacturing Practices (cGMP).

*   Execute analytical methods primarily using techniques such as HPLC, GC, UV-Vis, FTIR, titration, and dissolution testing as per approved pharmacopoeial (e.g., USP, EP) or internal specifications.

Documentation & Quality Systems

*   Author, review, and lead the preparation of high-quality technical documents including Standard Operating Procedures (SOPs), test methods, protocols, risk assessments (e.g., FMEA), and technical position papers.

*   Conduct thorough laboratory investigations for out-of-specification (OOS), out-of-trend (OOT), and aberrant results. Write detailed investigation reports, identify root causes, and implement effective corrective and preventive actions (CAPA) to prevent recurrence.

*   Manage deviations and non-conformances within the Quality Management System (QMS), ensuring they are documented, investigated, and closed in a timely manner.

*   Perform periodic reviews of laboratory documents (e.g., SOPs, test methods) to ensure they remain current, accurate, and reflective of actual practices.

Methodology & New Product Introduction

*   Provide active support for method transfer, verification, and validation activities for new product introductions. This includes executing validation protocols, analyzing data, and co-authoring validation reports to ensure methods are suitable for their intended use.

*   Assist in troubleshooting method-related issues and contribute to method improvement and optimization initiatives.

Laboratory Operations & Continuous Improvement

*   Manage the inventory of QC laboratory chemicals, reference standards, and critical consumables. Conduct regular stock checks, place orders, and ensure materials are received and stored correctly with proper documentation.

*   Maintain the laboratory in an audit-ready state, adhering to 5S principles and all Health, Safety, and Environmental regulations.

*   Actively participate in and contribute to continuous improvement initiatives, such as Practical Process Improvement projects, to enhance laboratory efficiency, quality, and safety.

*   Maintain personal training records to ensure full compliance with all required procedural and technical training.

REQUIREMENTS:
• Bachelor's degree, no prior experience required. Experience in quality control laboratory environment, preferably in pharmaceutical/biotech industry preferred

• Minimum of 2 years of relevant industrial experience within a cGMP-regulated environment, preferably in pharmaceuticals, biotechnology, or medical devices.
• Strong knowledge of cGMP, GLP, and quality management systems
• Proficiency in analytical techniques such as HPLC, ICP-MS, UV-Vis spectroscopy, and dissolution testing
• Ability to follow SOPs and maintain detailed documentation per GDP requirements
• Strong computer skills including LIMS, Microsoft Office, and analytical software
• Excellent attention to detail and organizational skills
• Strong analytical and problem-solving capabilities
• Ability to work both independently and collaboratively in a team environment
• Clear written and verbal communication skills
• Experience with laboratory equipment maintenance and calibration
• Knowledge of relevant pharmacopeia standards and regulatory requirements
• Ability to manage multiple priorities effectively
• Flexible scheduling may be required