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Change Control Specialist Jobs in Raleigh, NC (NOW HIRING)

Kelly Services

QA Systems Specialist

Raleigh, NC

$76K - $110K/yr

QA Systems Specialist Location: Raleigh NC, fully onsite Monday-Friday 8am-5pm Salary Range: $76 ... Support the administration of the Change Control system, including reviews, approvals, KPI tracking ...

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Change Control Specialist information

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How much do change control specialist jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for change control specialist in Raleigh, NC is $45.44, according to ZipRecruiter salary data. Most workers in this role earn between $41.35 and $47.45 per hour, depending on experience, location, and employer.

What is a change control specialist?

Change Control Specialists are professionals responsible for managing and overseeing changes to processes, systems, or products within an organization. Their main role is to ensure that any modifications are evaluated, approved, documented, and implemented in a controlled and systematic way to minimize risk and maintain compliance. They often work in regulated industries such as pharmaceuticals, manufacturing, or IT, where strict change management procedures are required. Change Control Specialists collaborate with cross-functional teams to assess the impact of proposed changes and ensure that all stakeholders are informed and involved.

What skills and qualifications are needed to be a change control specialist?

To thrive as a Change Control Specialist, you need strong organizational skills, attention to detail, and a background in quality assurance or regulatory compliance, often supported by a bachelor's degree in a relevant field. Familiarity with change management software, document control systems, and knowledge of industry standards like ISO or GMP is typically required. Excellent communication, problem-solving, and stakeholder management skills help in navigating complex processes and ensuring smooth implementation of changes. These skills are essential to maintain compliance, minimize operational risks, and ensure seamless adaptation to changes within regulated environments.

What are common challenges faced by change control specialists when coordinating cross-departmental change requests?

Change Control Specialists often encounter challenges such as aligning priorities between different departments, managing resistance to change, and ensuring all stakeholders are informed and compliant with change procedures. Effective communication and strong organizational skills are essential to coordinate approvals and maintain documentation accuracy. Regular meetings and clear documentation help streamline the process and minimize misunderstandings during implementation.

What is the difference between Change Control Specialist vs Quality Assurance Specialist?

AspectChange Control SpecialistQuality Assurance Specialist
Primary FocusManaging and documenting change processes in projects or manufacturingEnsuring products and processes meet quality standards
CertificationsISO 9001, CAPA, GMP knowledgeISO 9001, Six Sigma, GMP certifications
Work EnvironmentRegulated industries like pharma, manufacturing, biotechQuality departments across various industries
Key ResponsibilitiesChange request evaluation, approval, documentationAudits, inspections, process improvements

While both roles focus on compliance and process improvement, the Change Control Specialist primarily manages change processes, whereas the Quality Assurance Specialist ensures overall product quality. They often collaborate but serve distinct functions within regulated industries.

Is change control a difficult job?

Change Control Specialists are responsible for managing and documenting changes to processes, systems, or products, often requiring attention to detail, compliance knowledge, and communication skills. The job can be challenging due to the need for accuracy, adherence to regulations, and coordination across teams, but it is manageable with proper training and experience.

What does a change control specialist do?

A change control specialist manages and oversees the process of requesting, evaluating, approving, and implementing changes to projects, processes, or systems to ensure quality and compliance. They often work in regulated industries like pharmaceuticals or manufacturing, using tools like change control software and adhering to standards such as GMP or ISO. Their role involves documentation, risk assessment, and coordination with teams to minimize disruptions and maintain regulatory adherence.

What are popular job titles related to Change Control Specialist jobs in Raleigh, NC?

For Change Control Specialist jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Change Control Specialist jobs in Raleigh, NC look for?

The top searched job categories for Change Control Specialist jobs in Raleigh, NC are:

Change Control Specialist jobs near you
Infographic showing various Change Control Specialist job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 72% Full Time, 23% Part Time, and 4% Contract. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $94,508 per year, or $45.4 per hour.

Quality Control Specialist II

Novartis Group Companies

Morrisville, NC • On-site

$89K - $166K/yr

Other

Medical, Life, Retirement, PTO

Posted 4 days ago

Job description

Job Description Summary

#LI-Onsite
Location: Morrisville, North Carolina
The QC Specialist II is a highly skilled laboratory professional who will support the start-up and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, North Carolina. This role serves as a technical subject matter expert for complex analytical techniques and instrumentation while supporting analytical testing, investigations, method transfer, validation, and data review activities within a GMP-regulated environment.
Working within a growing site organization, the QC Specialist II will support the transfer, qualification, validation, and lifecycle management of analytical methods used to test pharmaceutical raw materials, in-process materials, finished products, and stability samples. The role will also provide technical leadership in troubleshooting, analytical investigations, equipment qualification, and training activities while partnering across Quality, Manufacturing, MS&T, Engineering, and Validation teams.
This is an exciting opportunity to help build the technical capabilities, laboratory systems, and quality infrastructure required to support the continued growth of the Morrisville manufacturing site.


Job Description

Key Responsibilities
  • Serve as a subject matter expert for complex analytical techniques and instrumentation, including HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, spectroscopy, and physicochemical testing.
  • Perform and troubleshoot chromatographic and wet-chemistry testing of raw materials, in-process materials, finished products, and stability samples in compliance with GLP and cGMP requirements.
  • Manage analytical method transfers, validation, troubleshooting, risk mitigation, and lifecycle-management activities to support the Morrisville Quality Control laboratory.
  • Lead and support OOS and deviation investigations, including root-cause analysis, CAPA definition, issue resolution, and KPI/KQI trending.
  • Review and approve chromatographic and non-chromatographic data and analytical tests, ensuring data integrity, accuracy, and readiness for analytical release.
  • Provide expert support for laboratory equipment and system qualification and validation, including user requirements specifications, functional specifications, IQ/OQ/PQ activities, calibration, maintenance, and qualification-plan preparation.
  • Develop and deliver site training for Empower CDS, complex analytical technologies, laboratory processes, and applicable quality requirements.
  • Ensure activities comply with GxP, ALCOA+ data-integrity principles, regulatory requirements, and Novartis policies while collaborating across QA, QC, MS&T, Engineering, Operations, and other site functions.
Essential Requirements
  • Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline, with working experience in technical drug development, manufacturing, analytics, or quality within a cGMP-regulated environment.
  • Hands-on experience with HPLC, GC, UPLC, and/or LC-MS analysis, including experience with analytical method validation and transfer; experience with LabWare LIMS and Empower CDS is preferred.
  • Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management.
  • Strong technical knowledge of complex analytical techniques, such as HPLC, UPLC, GC, ICP, dissolution, LC-MS, spectroscopy, and physicochemical testing.
  • Good understanding of GxP, ALCOA+ data-integrity principles, ICH Q2, ICH Q10, ICH Q14, and relevant FDA, EMA, and other regulatory expectations.
  • Broad knowledge of cGMP requirements and experience working within technical drug development, manufacturing, analytical, or quality operations.
Desirable Requirement
  • Prior experience developing and delivering technical training related to analytical instrumentation, laboratory systems, or quality control processes.

The salary for this position is expected to range between $89,600 - $166,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$89,600.00 - $166,400.00


Skills Desired

Analytical Testing, Collaboration, Communication, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Managing Ambiguity, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Validation Activities

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