Overview
Quality Specialist Jobs in Wilson, North Carolina, USA at Astrix
This range is provided by Astrix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$40.00/hr – $45.00/hr
We are seeking a detail-oriented, proactive, and experienced Quality Assurance Specialist to join our team. In this role, you will support a broad range of Quality Assurance activities including batch record management, product release, documentation review, and compliance functions in a GMP-regulated pharmaceutical manufacturing environment. This is a vital position that ensures all site operations meet regulatory standards and company quality expectations.
Location:
Wilson, NC
Terms:
Contract (1 year)
Pay: $40.00 – $45.00/hr
Key Responsibilities:
Manage and maintain site Batch Records: retrieval from operations, archiving, scanning (for Canadian market), and filing in document retention systems.
Oversee the tracking, storage, and destruction of batch records in accordance with retention policies.
Prepare and provide Certificates of Compliance (CoC) and Certificates of Analysis (CoA) for finished goods and associated bulk drug product batches.
Support SAP-based batch/material allocation for global markets via Registered Country Table (RCT) processes.
Execute batch record reviews and support release of intermediate and finished products for the domestic market.
Review and approve GMP-related SOPs; assist in SOP development to enhance compliance.
Participate in investigation root cause analysis, corrective/preventive action (CAPA) planning, and material disposition.
Own and complete QA investigations as assigned.
Support internal/external audits and regulatory inspections by compiling relevant quality data.
Participate in Quality Master Data management, project strategy meetings, and PCR implementation.
Identify and implement continuous improvement initiatives for quality and operational excellence.
Maintain 5S standards and promote a safe, compliant workplace.
Qualifications:
Education: Bachelor’s degree (B.A./B.S.) in Science, Engineering, or a related discipline required.
Experience: Minimum 3 years in a GMP pharmaceutical manufacturing environment, with direct or indirect involvement in Quality functions.
Systems: Advanced proficiency in SAP and Veeva systems preferred.
Skills:
Strong problem-solving, attention to detail, and time management abilities.
Proven communication and teamwork capabilities—both written and verbal.
Ability to analyze data, generate reports, and drive continuous improvements.
Knowledge of FDA regulations, GMP, ISO, DEA, and EPA compliance.
Capable of managing multiple tasks under pressure and meeting project deadlines.
Why Join Us?
This is a dynamic opportunity to bring your quality expertise into a collaborative, innovation-driven environment where your contributions ensure product integrity and patient safety. If you’re passionate about quality and compliance in pharmaceutical manufacturing, we’d love to hear from you.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Title: Quality Specialist
Company: Astrix
Location: Wilson, North Carolina, USA
Category: Quality Assurance – QA/QC (Data Analyst)
