QC Scientist II - Raw Materials

Location/Division Specific Information

Position supports the High Point, NC site and the Drug Product Division (DPD).

Schedule

Standard (Mon-Fri), 1st Shift, and may require flexible scheduling including occasional weekend work. Laboratory setting.

About the Role

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.

Responsibilities

• Execute validated test methods
• Participate in method development and validation activities
• Investigate out-of-specification results
• Maintain detailed documentation of analyses
• Contribute to continuous improvement initiatives
• Help establish robust analytical processes while adhering to cGMP requirements and safety standards
• Work with cross-functional teams

Education and Experience

• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in a GMP regulated laboratory environment performing analytical testing required
• Preferred fields of study: Chemistry, Biology, Biochemistry, or related scientific field
• Experience with laboratory information management systems (LIMS) and quality management systems
• Experience with method validation and transfer activities preferred

Knowledge, Skills, and Abilities

• Expertise in analytical techniques such as HPLC, GC, CE, ELISA, PCR, and other bioanalytical methods
• Proficient in aseptic techniques and environmental monitoring procedures
• Strong knowledge of cGMP regulations and quality control requirements
• Excellent documentation practices and attention to detail
• Strong problem-solving and analytical skills
• Ability to work both independently and collaboratively
• Proficiency with Microsoft Office applications
• Strong written and verbal communication skills
• Ability to lift up to 30 pounds and stand for extended periods
• Willingness to wear required PPE including lab coat, safety glasses, and gloves
• Knowledge of data integrity requirements and good documentation practices
• Demonstrated ability to investigate out-of-specification results and author technical reports

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.