QC Analyst (Raleigh, US)

NCBiotech; Raleigh (NC); On-site; USD 65,000 - 100,000; Full time

Job summary

Guerbet is seeking a QC Analyst to perform routine and non-routine laboratory testing in a cGMP environment, report data with ALCOA+ integrity, and support investigations and method validation. You will work with raw materials and finished products, apply SOPs, and help maintain instrumentation while collaborating with QA and manufacturing teams.

The role requires a bachelor's degree in chemistry or related field and at least 4 years of GMP experience, with exposure to analytical equipment

Qualifications

• Bachelor’s degree in chemistry or related field required.

Responsibilities

• Performs routine and advanced laboratory testing, including wet chemistry, analytical assays, and raw material testing.

Education

Bachelor’s degree in chemistry or related field

Tools

HPLC

GC

Dissolution

Spectroscopy

LIMS/Empower-CDS

Job description

QC Analyst

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The QC Analyst operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The QC Analyst performs routine and non-routine laboratory testing in compliance with applicable safety, quality, and regulatory standards. This role demonstrates increased technical proficiency, independence, and problem-solving capability, supporting laboratory operations including finished product and raw material testing, investigations, and continuous improvement within a cGMP-regulated environment.

YOUR ROLE

• Performs routine and advanced laboratory testing, including wet chemistry, analytical assays, and raw material testing, in accordance with approved SOPs
• Accurately records, analyzes, and reports laboratory results in compliance with data integrity (ALCOA+) standards
• Identifies, documents, and reports out-of-specification (OOS), out-of-trend (OOT), or atypical results
• Independently supports and contributes to investigations, including root cause analysis and documentation
• Reviews data for accuracy, completeness, and compliance with procedures
• Maintains, troubleshoots, and ensures proper functionality of laboratory instrumentation
• Authors and revises SOPs, test methods, and laboratory documentation as needed
• Participates in method verification, method transfer, validation activities and raw material qualification support under limited supervision
• under limited supervision
• Performs sampling, testing, and evaluation of raw materials and components in accordance with specifications and compendial requirements
• Follows GMP, safety, and regulatory requirements to maintain compliance and audit readiness
• Collaborates with manufacturing, formulation, packaging, and QA teams to support production and quality objectives
• Supports sample management activities (receipt, labeling, storage, and tracking)
• Actively participates in training, cross-training, and continuous improvement initiatives
• May provide guidance and training to junior analysts
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications:

• Bachelor’s degree in chemistry or related scientific field (or equivalent experience)
• 4+ years of laboratory or analytical experience with demonstrated technical proficiency (GMP environment preferred)

Preferred Qualifications:

• Working knowledge of cGMP, USP, and regulatory expectations
• Hands-on experience with raw material testing, specification evaluation, and/or incoming material inspection activities
• Experience with analytical instrumentation (e.g., HPLC, GC, dissolution, spectroscopy)
• Experience with laboratory systems (e.g., LIMS, Empower/CDS)
• Demonstrated ability to support investigations, method activities, and technical problem-solving

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]