Top 31 Software quality assurance analysts and Jobs in Durham, Nc

QC Chemistry Lead
Guerbet —Raleigh, NC
- Full-time
- 5 years
- Computer literacy
- Master's degree
10d
Compliance - Quality Assurance Analyst
TruTechnologies —Durham, NC
- Full-time
- Office
- Bachelor's degree
- Leadership
19h
Quality Assurance Engineer
HEALTHPLANONE, LLC —Cary, NC
- Full-time
- Computer science
- Computer Science
- Writing skills
- Health insurance
Quick Apply
8d
Software Quality Analyst
Computer World Services —Morrisville, NC
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Mid-level
Systems Analyst
Fidelity TalentSource —Durham, NC
- Email
- Bachelor of Science
- Office
- SQL
1d
Applications Systems Analyst I
State of North Carolina - Health & Human Services —Wake County, NC
- $70,528 - $105,793 a year
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- High school diploma or GED
- Paid parental leave
- Health insurance
Quality Analyst 2
Garmin International, Inc. —Cary, NC
- Full-time
- Writing skills
- Mid-level
- Office
Lead Software Development Engineer Test
MetLife —Cary, NC
- $134,690 - $175,600 a year
- Email
- Hybrid work
- 7 years
- Office
- Java
- Paid holidays
- Disability insurance
7d
Application Analyst - Clinical & Business - Level 2
Duke Health —Durham, NC
- Full-time
- Customer service
- Research
- Mid-level
Application Analyst - Maestro Care Beaker - Level 2
Duke Health —Durham, NC
- Full-time
- Azure
- Writing skills
- System design
- Opportunities for advancement
4d
Child Support Functional Analyst
State of North Carolina - Health & Human Services —Wake County, NC
- $57,983 - $107,470 a year
- Full-time
- Hybrid work
- Research
- Mid-level
- Office
- Paid parental leave
- Health insurance
Application Analyst - Maestro Care Concierge Level 2
Duke Health —Durham, NC
- Full-time
- Writing skills
- System design
- Mid-level
- Opportunities for advancement
4d
Internal Auditor II (Full-time Remote, North Carolina Based)
Alliance Health —Morrisville, NC
- $89,404 - $113,990 a year
- Full-time
- Remote
- Microsoft Excel
- CPA
- 3 years
- Disability insurance
- Health insurance
Quality Analyst
Leader Communications Inc —Raleigh, NC
- Full-time
- Mid-level
- 3 years
- Mentoring
Quick Apply
Sr. Software Developer- Contractor
Align Technology —Raleigh, NC
- Contract
- Databases
- AWS
- US work authorization
Quick Apply
Senior Quality Analyst
Garmin International, Inc. —Cary, NC
- Full-time
- Office
- Analysis skills
- Bachelor's degree
21h
Network Analyst II
State of North Carolina - Health & Human Services —Wake County, NC
- $75,818 - $113,727 a year
- Full-time
- Computer science
- Computer Science
- High school
- Paid parental leave
- Health insurance
Lead Software Systems Engineer
Cadence Design Systems —Cary, NC
- Full-time
- Computer Science
- System design
- Mid-level
Applications Systems Analyst II - EHRA
State of North Carolina - Department of Information Technology —Wake County, NC
- $81,504 - $122,256 a year
- Full-time
- Hybrid work
- Computer Science
- Research
- Mid-level
Senior Vice President of Product
Digital.ai —Raleigh, NC
- $250,000 - $275,000 a year
- Full-time
- Remote
- Writing skills
- 11+ years
- Analysis skills
- Paid parental leave
- Health insurance
Quick Apply
3d

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QC Chemistry Lead

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time
10 days ago

Qualifications

Computer operation
Drug regulation
Chemist team management
Data integrity and documentation
Pharmaceutical company experience
Pharmaceutical analysis
Chemical testing

Full Job Description

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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The QC Chemistry Lead 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.

At the Guerbet Raleigh Imaging manufacturing facility, the Quality Control Lead is responsible for overseeing analytical testing and quality assurance processes within the chemistry lab. This role ensures compliance with cGMP (Current Good Manufacturing Practices), ICH guidelines, and regulatory standards while leading a team of chemists to maintain the integrity and accuracy of pharmaceutical products.

YOUR ROLE

Lead, support, and mentor a team of QC chemists, ensuring adherence to laboratory protocols and regulatory requirements.
Oversee the testing of raw materials, in-process samples, finished drug substances, and stability studies to ensure product quality.
Implement and maintain quality control procedures to ensure compliance with FDA, EMA, and other regulatory agencies.
Conduct investigations into out-of-specification (OOS) results and deviations (EXC), implementing corrective and preventive actions (CAPA).
Ensure proper documentation and data integrity in accordance with Good Laboratory Practices (GLP).
Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to support product development and release.
Maintain and troubleshoot laboratory instruments such as HPLC, FTIR, UV-Vis Spectrophotometers, and other analytical equipment.
Lead audits and inspections, ensuring readiness for regulatory reviews.
Provide training and guidance to QC staff on analytical techniques and compliance standards.
Ensure testing is performed in compliance with USP/EP/JP and internal specifications, SOPs, and cGMP standards.
Participate in method transfers, validations, and verifications.
Maintain lab readiness for regulatory inspections and internal audits.
Train, mentor, and evaluate lab analysts; ensure proper documentation and lab safety practices.
Support continuous improvement projects, including implementation of new equipment, methods, or automation tools
Performs other duties as assigned by management

YOUR BACKGROUND

Education: Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related scientific discipline.
5+ years of pharmaceutical QC laboratory experience with a strong background in analytical chemistry.
1–3 years in a leadership or senior analyst role preferred.
Proficiency with HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry.
Familiarity with LIMS, CDS (e.g., Empower), and laboratory instrumentation qualification.
Strong understanding of cGMP, FDA, ICH, and USP guidelines.
Knowledge of industry regulations and best practices for data integrity.
Effective communication and problem-solving skills.
Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements
Demonstrated auditing and corrective action proficiency.
Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.

Cognitive Requirements:

Ability to read and understand military time.
Experience in data quality control, auditing, or regulatory compliance.
Strong analytical skills and attention to detail.
Excellent leadership and team management abilities.
Proficiency in data management tools and software.
Excellent problem solving and decision-making skills.
Ability to manage and drive change
Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.
Computer skills
Knowledge of document management/quality systems
Ability to manage projects and processes with multiple functional groups without direct reporting authority
Strong communication and interpersonal skills
Getting work done through others that are not direct reports
Operates with minimal direction, self-starter
Building relationships with other departments

Apply Now

Refine Your Search

software quality assurance analysts and jobs in durham, nc

QC Chemistry Lead

Compliance - Quality Assurance Analyst

Quality Assurance Engineer

Software Quality Analyst

Systems Analyst

Applications Systems Analyst I

Quality Analyst 2

Lead Software Development Engineer Test

Application Analyst - Clinical & Business - Level 2

Application Analyst - Maestro Care Beaker - Level 2

Child Support Functional Analyst

Application Analyst - Maestro Care Concierge Level 2

Internal Auditor II (Full-time Remote, North Carolina Based)

Quality Analyst

Sr. Software Developer- Contractor

Senior Quality Analyst

Network Analyst II

Lead Software Systems Engineer

Applications Systems Analyst II - EHRA

Senior Vice President of Product

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