QA Specialist

Job Description

Job Description

Job Title: QA Specialist Job Description

The QA Specialist ensures that all operations meet current Good Manufacturing Practices (cGMP) and internal standard operating procedures (SOPs), with a strong focus on document review, technical writing, and support of process validation activities for commercial pharmaceutical manufacturing. This role is ideal for a quality professional with pharmaceutical GMP experience who wants to contribute to a large, high-impact project while maintaining rigorous compliance and documentation standards.

• Assure quality and compliance with all GMP regulations and internal SOPs across assigned activities.
• Perform quality review and approval of documents, data, basic protocols, and reports to ensure accuracy, completeness, and compliance.
• Conduct quality floor audits and inspections to verify adherence to cGMP and internal procedures.
• Provide quality evaluation and release of support materials and intermediate products as required.
• Assist with quality improvement initiatives to enhance processes, systems, and documentation.
• Assist with the development and revision of SOPs and other quality-related documents.
• Write, review, and approve change controls, deviations, corrective and preventive actions (CAPA), out-of-specification (OOS) reports, and raw material specifications.
• Support batch record review and data review activities to ensure products and processes meet quality standards.
• Participate in client audits and regulatory inspections, providing documentation and responses as needed.
• Maintain accurate, organized files and records in accordance with company policies and regulatory requirements.
• Comply with all company policies and SOPs and promote a culture of quality and compliance.
• Ensure timely completion of all required cGMP and company training, maintaining up-to-date knowledge of relevant regulations and procedures.

• Previous pharmaceutical GMP experience, with a strong understanding of cGMP regulations and quality systems.
• Hands-on experience with batch record review and data review in a GMP environment.
• Demonstrated experience in technical writing, including authoring and reviewing change controls, deviations, and quality documentation.
• Experience with investigations related to quality events, deviations, or nonconformances.
• Ability to perform and document quality floor audits and inspections.
• Strong attention to detail and ability to maintain accurate, compliant documentation and records.
• Ability to interpret and apply SOPs, regulatory guidelines, and quality standards in daily work.
• Strong organizational and time management skills to ensure timely completion of quality tasks and training.

• Exposure to process validation for commercial manufacturing, particularly within a pharmaceutical environment.
• Experience supporting quality aspects of large-scale or high-visibility projects.
• Familiarity with CAPA and OOS processes, including root cause analysis and implementation of corrective and preventive actions.
• Ability to collaborate effectively with cross-functional teams, including manufacturing, quality, and regulatory groups.
• Strong written and verbal communication skills to clearly document and explain quality decisions and findings.

This position is based on site in Cary, NC, working standard business hours in a pharmaceutical manufacturing and quality environment. The role involves regular interaction with production areas and quality systems, participation in audits and inspections, and close collaboration with technical and operational teams. The QA Specialist supports process validation activities for a large, impactful project, offering the opportunity to work in a dynamic setting where compliance, documentation accuracy, and continuous improvement are highly valued.

This is a Contract position based out of Cary, NC.

The pay range for this position is $45.00 - $55.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Cary, NC.

This position is anticipated to close on Oct 26, 2026.

This is a fully onsite position in Cary,NC.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.