GMP Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist provides critical support to Quality Operations with a primary focus on material and batch release activities in a fast-paced pharmaceutical and cell therapy environment. Working within established GMP processes and under moderate supervision, this role helps maintain compliance with Good Manufacturing Practices (GMP) and current Good Practices (cGxP) regulations. The specialist applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities that contribute to the manufacture of an innovative cell therapy for chronic kidney disease.

Responsibilities

• Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases in accordance with established procedures.
• Prepare and conduct initial reviews of batch and material release documentation to ensure conformance with applicable SOPs, specifications, and acceptance criteria.
• Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and internal requirements, and escalate discrepancies to QA staff.
• Report key quality metrics and performance indicators using established templates and reporting tools.
• Perform hands-on monitoring of production and non-production activities, identifying and promptly reporting observed non-compliance to Quality Management.
• Support confirmation that finished products conform to internal standards and applicable cGxP regulations.
• Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management.
• Assist in the investigation of deviations under the guidance of QA staff, contributing to root cause identification and proposing corrective actions for review and approval.
• Identify compliance risks and clearly communicate observations to management, supporting implementation of assigned action plans to mitigate risks.
• Promptly escalate critical quality issues to management with relevant documentation and context.
• Regularly review and update GMP system procedures, as assigned, to ensure alignment with current regulatory standards and company policies.
• Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
• Assist in the implementation and maintenance of regulated Quality Systems under the direction of QA personnel.
• Support audit preparation activities and contribute to continuous improvement of manufacturing quality and quality assurance processes.

Essential Skills

• Associate’s Degree and years of relevant experience in a GMP-regulated environment, or a Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, or a related field with 2 years of relevant experience in a GMP-regulated environment.
• Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations.
• Experience with batch record review and material release documentation.
• Familiarity with deviation management and CAPA processes, with experience participating in or supporting investigations preferred.
• Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred.
• Hands-on experience in Quality Assurance within pharmaceutical, biotech, or manufacturing quality environments.
• Ability to perform inspection, document control, and audit support activities in compliance with established procedures.
• Strong attention to detail and accuracy in documentation, data entry, and record review.
• Effective written and verbal communication skills to clearly document findings and communicate quality issues.
• Ability to identify compliance risks and escalate issues appropriately within Quality and management.

Additional Skills & Qualifications

• Experience working in GMP-regulated pharmaceutical or cell or gene therapy manufacturing environments.
• Exposure to cell therapy or advanced therapy medicinal products and an interest in innovative therapies for chronic kidney disease.
• Experience supporting audit preparation and participating in internal or external audits.
• Demonstrated ability to support investigation and analysis activities related to deviations and CAPA.
• Comfort working in a fast-paced environment with evolving quality system requirements.
• Strong organizational skills and the ability to manage multiple quality tasks and priorities.
• Ability to collaborate effectively with cross-functional manufacturing and quality teams.

Work Environment

The role is based in both laboratory and office settings within a GMP-regulated pharmaceutical and cell therapy manufacturing environment. The laboratory work takes place in cleanrooms classified as 10K and 100K, requiring strict adherence to sterile gowning procedures and the ability to obtain and maintain sterile gowning certification. The position involves working around regulated manufacturing operations, quality systems, and documentation processes that support the production of an innovative, minimally invasive, percutaneous injectable cell therapy prepared from a patient’s own kidney cells. The environment emphasizes high standards of cleanliness, regulatory compliance, and careful handling of materials and documentation, with regular interaction between lab and office-based activities.

This is a Contract to Hire position based out of WINSTON SALEM, NC.

The pay range for this position is $30.00 - $35.00/hr.

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 fully onsite position in WINSTON SALEM,NC.

This position is anticipated to close on May 15, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 actalentaccommodation@actalentservices.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.

Salary : $30 - $35