QA Specialist

QA Specialist

Our client, a leader in pharmaceutical manufacturing and quality assurance, is seeking a QA Specialist to join their team. As a QA Specialist, you will be part of the Quality Assurance department supporting the clinical trial manufacturing and packaging processes. The ideal candidate will have meticulous attention to detail, strong communication skills, and a proactive approach to problem-solving, which will align successfully in the organization.

Job Title: QA Specialist

Location: Zebulon, NC

Pay Range: $45

Duration: 12 months

What's the Job?

• 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.

What's Needed?

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

What's in it for me?

• Opportunity to work in a dynamic and 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.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay