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Quality Assurance Biotech Jobs in Raleigh, NC (NOW HIRING)

DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

... biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement * Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S ...

Kelly Services

Sr QA Operations Manager

Raleigh, NC

$175K/yr

Extensive experience in pharmaceutical or biotech manufacturing under GMP regulations. * Strong experience in QA oversight of operations and sterile manufacturing preferred. * Proven leadership in ...

Kelly Services

QA Systems Specialist

Raleigh, NC

$76K - $110K/yr

Minimum of five (5) years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry. * Experience supporting Quality Systems, Quality Assurance, Manufacturing Quality ...

LeadStack Inc.

GMP QA Validation Specialist

Durham, NC

$45 - $53/hr

QA Validation Specialist Location: Research Triangle Park, NC - 27709 Duration: 10 Months Pay Rate ... biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or ...

LeadStack Inc.

GMP QA Validation Specialist

Durham, NC

$45 - $53/hr

QA Validation Specialist Location: Research Triangle Park, NC - 27709 Duration: 10 Months Pay Rate ... biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or ...

Fujifilm

Specialist, Quality Assurance

Durham, NC · On-site

Position Overview The QA Operations Specialist is responsible for providing quality oversight of ... booming biotech hub surrounded by top universities, vibrant communities, and various outdoor ...

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How much do quality assurance biotech jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for quality assurance biotech in Raleigh, NC is $28.47, according to ZipRecruiter salary data. Most workers in this role earn between $18.22 and $33.41 per hour, depending on experience, location, and employer.

What is a quality assurance biotech?

A Quality Assurance (QA) Biotech job involves ensuring that biotechnology products meet regulatory and company standards for safety, efficacy, and quality. QA professionals develop and implement quality systems, conduct audits, review documentation, and ensure compliance with Good Manufacturing Practices (GMP) and other regulations. They collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to maintain product integrity. Their role is critical in preventing defects, ensuring consistent processes, and maintaining compliance with industry standards.

What are the key skills and qualifications needed to thrive in quality assurance biotech?

To thrive as a Quality Assurance Biotech, you need a solid understanding of biotechnology processes, quality control methodologies, and regulatory standards such as GMP, often supported by a degree in biology, chemistry, or a related field. Familiarity with laboratory information management systems (LIMS), documentation software, and industry certifications like ASQ or GMP training is highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills are valued soft skills in this role. These abilities ensure precise compliance with regulatory requirements, facilitate collaboration with cross-functional teams, and help maintain the integrity and safety of biotech products.

What are the most common challenges faced by quality assurance professionals in the biotech industry?

Quality Assurance professionals in biotechnology often encounter challenges related to staying up-to-date with evolving regulatory requirements and ensuring that all processes consistently meet strict quality standards. Additionally, managing thorough documentation and collaborating across various departments—such as research, manufacturing, and regulatory affairs—can be complex. Those in the role may also need to respond quickly to deviations or quality events, requiring both proactive problem-solving and excellent organizational skills. However, overcoming these challenges is highly rewarding, as it directly contributes to maintaining the safety and efficacy of biotech products.

What are the most commonly searched types of Quality Assurance Biotech jobs in Raleigh, NC? The most popular types of Quality Assurance Biotech jobs in Raleigh, NC are:
What are popular job titles related to Quality Assurance Biotech jobs in Raleigh, NC? For Quality Assurance Biotech jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Quality Assurance Biotech jobs in Raleigh, NC look for? The top searched job categories for Quality Assurance Biotech jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Quality Assurance Biotech jobs? Cities near Raleigh, NC with the most Quality Assurance Biotech job openings:
Quality Assurance Biotech jobs near you
Infographic showing various Quality Assurance Biotech job openings in Raleigh, NC as of August 2026, with employment types broken down into 100% Contract. Highlights an 100% In-person job distribution, with an average salary of $59,220 per year, or $28.5 per hour.

Quality Assurance (QA) Engineer / Senior QA Specialist (TEST)

TiltEdge Solutions LLC

Raleigh, NC • On-site

Contractor

Re-posted 18 days ago

Job description

Quality Assurance (QA) Engineer / Senior QA Specialist (TEST)

Experience Required: 7–10 Years

Location: Raleigh, NC

Visa: US Citizen / Green Card

Mode of Work: In-office

Duration: 10 to 12 months +

Role Overview

The QA Engineer / Senior QA Specialist will provide experienced, hands-on quality oversight for commercial GMP manufacturing operations. This role requires strong judgment, deep knowledge of GMP regulations, and the ability to independently manage quality events while partnering closely with Manufacturing, Validation, and Engineering teams in a regulated environment.

Key Responsibilities

* Provide independent QA oversight for commercial GMP manufacturing operations in compliance with 21 CFR Parts 210/211, EU GMP, and ICH Q10.

* Own and manage deviations, CAPAs, and change controls in TrackWise, including leading investigations, performing root cause analysis, assessing product impact, and ensuring timely, effective closure.

* Review and approve validation and qualification documentation (including IQ/OQ/PQ, protocols, reports, and summary documentation) using Kneat, ensuring compliance with GMP, data integrity, and regulatory expectations.

* Perform thorough batch record review and release support, identifying trends, risks, and opportunities for process improvement.

* Support equipment lifecycle activities, including maintenance, calibration, and qualification, through review of GMP documentation and records in CMMS.

* Review, approve, and maintain controlled documents, SOPs, and training records in Veeva Vault, ensuring accuracy, compliance, and inspection readiness.

* Contribute to the development, revision, and continuous improvement of QA procedures, processes, and documentation to support operational readiness and manufacturing excellence in a cGMP facility.

* Serve as a QA point of contact for manufacturing operations, providing guidance on GMP expectations, deviation handling, and change implementation.

* Support regulatory inspections, internal audits, and customer audits, including preparation, participation, and follow-up actions.

* Mentor junior QA team members and provide guidance on GMP best practices, as needed.

Systems & Tools

* TrackWise – Deviations, CAPAs, Change Control

* Kneat – Validation, Qualification, Batch Record Review

* Veeva Vault – Document and Training Management

* CMMS – Equipment Maintenance and Calibration Records

Qualifications

* Bachelor’s degree in Science, Engineering, or a related discipline (or equivalent experience).

* 7–10 years of Quality Assurance experience in a cGMP-regulated environment (pharmaceutical, biotech, or related industry).

* Strong working knowledge of FDA, EU, and ICH GMP regulations.

* Proven experience independently managing quality investigations, change controls, and validation documentation.

* Experience supporting commercial manufacturing operations.

* Strong communication, documentation, and cross-functional collaboration skills.

* Demonstrated ability to work independently while balancing multiple priorities in a fast-paced GMP environment