QC Scientist II - QC Analytical

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products 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.

Division / Site Information

Join Thermo Fisher Scientific’s Pharma Services Group, where quality and compliance are at the core of everything we do. This role supports GMP manufacturing and quality control laboratories responsible for testing biopharmaceutical products across early-stage clinical development through commercial release.

You will work on-site in a regulated laboratory environment, collaborating with cross-functional teams to ensure the highest standards of product quality, safety, and complian

DESCRIPTION:
You'll perform sophisticated analyses to ensure product quality and safety in our laboratories. As a QC Scientist II, you'll conduct complex analytical testing to support GMP manufacturing of biopharmaceutical products, from early-stage clinical development through commercial release. You'll work with analytical instruments and technologies while making a meaningful impact on patient health through precise quality control testing.

Working with cross-functional teams, you'll execute validated test methods, participate in method development and validation activities, investigate out-of-specification results, and maintain detailed documentation of analyses. You'll contribute to continuous improvement initiatives and help establish robust analytical processes while adhering to cGMP requirements and safety standards.

A Day in the Life

You will:

• Perform complex analytical testing in support of GMP manufacturing, including in-process, release, and stability testing

• Execute validated test methods and support method development, validation, and transfer activities

• Operate and troubleshoot analytical instrumentation such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical platforms

• Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, including root cause analysis and technical report authorship

• Maintain accurate, thorough, and compliant documentation in accordance with cGMP and data integrity requirements

• Utilize Laboratory Information Management Systems (LIMS) and quality management systems to document and review data

• Support health authority and internal audits, inspections, and regulatory commitments

• Collaborate with manufacturing, quality assurance, and development teams to resolve issues and improve analytical processes

• Participate in continuous improvement initiatives to enhance laboratory efficiency, compliance, and robustness

• Follow all safety, aseptic technique, and environmental monitoring requirements

Keys to Success

Education

• Advanced degree (MS or PhD) in Chemistry, Biology, Biochemistry, or a related scientific field with no prior experience, or

• Bachelor’s degree in a scientific discipline with 2+ years of experience in a GMP-regulated laboratory environment performing analytical testing

Experience

• Hands-on experience with analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods

• Experience working in a cGMP-regulated environment

• Demonstrated experience investigating OOS results and authoring technical documentation

• Experience with method validation and method transfer activities preferred

• Familiarity with health authority audits and regulatory inspections

Knowledge, Skills, and Abilities

Knowledge

• Strong understanding of cGMP regulations, quality control principles, and data integrity requirements

• Knowledge of aseptic techniques and environmental monitoring procedures

Skills

• Profic