QA Specialist

Location: Zebulon, NC • Duration: 12 months • Pay Range: $45/hour

About the role

Serve as a Batch Release Officer for the review and recommended release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP requirements. Assess Quality QMS Records such as Deviations and complaints, make recommendations for corrective and preventative actions, and follow up on their implementation. Review and approve GMP documentation, including Standard Operating Procedures, Change Controls, and other controlled documents from business partner areas. Provide advice and support to business partner areas relating to quality matters and process improvements. Participate in audits, assessments, regulatory inspections, and high-priority projects, including addressing non-compliance issues.

Responsibilities

• Review and recommend release of GMP documentation for clinical-trial dosage forms and finished packs.
• Assess QMS records (Deviations, Complaints) and drive CAPA implementation.
• Review and approve SOPs, Change Controls, and other controlled documents.
• Advise business partners on quality matters and process improvements.
• Participate in audits, regulatory inspections, and high-priority projects.

Requirements

• Bachelor’s degree or equivalent work experience with 5+ years in a similar QA role.
• Experience reviewing GMP manufacturing, packaging, or laboratory records for pharmaceutical dosage forms.
• Knowledge of GMP principles and decision-making based on GMP standards.
• Experience leading or participating in QMS activities (Deviations, Complaints, Change Controls, audits).
• Proficient in Microsoft Windows applications (Word, Excel, PowerPoint).

Benefits

Upon completion of the waiting period, consultants are eligible for:

• Medical and prescription drug plans
• Dental and vision plans
• Health Savings Account and Flexible Spending Accounts (Health & Dependent Care)
• Supplemental life insurance
• Short-term and long-term disability insurance
• Business travel insurance
• 401(k) with company match
• Weekly pay

Why join

• Opportunity to work in a dynamic, impactful environment dedicated to quality and compliance.
• Engagement in meaningful projects that support global health initiatives.
• Collaborative team culture that values innovation and continuous improvement.
• Professional growth through exposure to regulatory inspections and high-priority initiatives.
• Competitive pay rate aligned with industry standards.