QC Scientist II QC Analytical

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Division / Site Information

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

Working with cross-functional teams youll execute validated test methods participate in method development and validation activities investigate out-of-specification results and maintain detailed documentation of analyses. Youll 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

• Bachelors 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

• Proficiency with Microsoft Office applications

• Experience with LIMS and electronic quality management systems

• Strong problem-solving analytical and organizational skills

• Excellent written and verbal communication skills

Abilities

• Ability to work independently and collaboratively in a fast-paced laboratory environment

• Ability to manage multiple priorities while maintaining attention to detail

• Willingness to work flexible schedules including occasional weekend work

Physical Requirements / Work Environment

• Ability to lift up to 30 pounds

• Ability to stand for extended periods

• Willingness to wear required PPE including lab coat safety glasses and gloves

• Work performed in a laboratory environment with exposure to chemicals and biological materials

Benefits

We offer competitive remuneration an annual incentive plan and a comprehensive benefits package starting Day 1 including:

• Medical Dental and Vision coverage

• Paid Time Off and designated paid holidays

• Retirement Savings Plan

• Tuition Reimbursement

• Career development and growth opportunities

Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and an inclusive culture that values Integrity Intensity Involvement and Innovation.

Relocation assistance is NOT provided

Must be legally authorized to work in the United States without sponsorship now or in the future.

Must be able to pass a comprehensive background check which includes a drug screening.