QA Specialist

• QA Specialist
• Shift: 1st Shift (8am-5pm)
• Schedule: Monday-Friday
• Pay: $25–$27/hr.

Position Summary

We are seeking a detail-oriented QA Specialist – Batch Release to support quality assurance and batch release activities in a GMP-regulated environment. This role will be responsible for reviewing batch documentation, preparing quality documentation, approving raw materials, releasing materials in SAP, and communicating with clients regarding quality-related matters.

Key Responsibilities

• Review and approve batch records to ensure accuracy, completeness, and compliance with GMP requirements.
• Prepare and document deviations, NOEs (Notice of Events), and other quality documentation.
• Release materials and complete required transactions in SAP on a daily basis.
• Review and approve raw materials and associated documentation.
• Review Certificates of Analysis (COAs) for accuracy and compliance with specifications.
• Ensure batch release activities are completed accurately and within required timelines.
• Maintain accurate QA records and documentation.
• Communicate with clients regarding quality, batch release, documentation, and product-related questions.
• Provide professional customer service and respond to client requests in a timely manner.
• Work closely with Production, Quality Control, Operations, and other departments to resolve quality-related issues.
• Ensure all work is performed in accordance with applicable GMP procedures, SOPs, and quality standards.
• Identify discrepancies and assist with investigations and corrective actions as needed.
• Utilize Microsoft Excel and other computer systems to maintain and review quality information.

Required Qualifications

• Experience working in a GMP-regulated environment.
• Strong technical writing skills.
• Proficiency with Microsoft Excel.
• Excellent attention to detail and strong organizational skills.
• Ability to review detailed documentation and identify errors or discrepancies.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Customer-service mindset with the ability to communicate professionally with clients.

Preferred Qualifications

• Previous experience with SAP, particularly for material transactions or batch release activities.
• Previous experience in QA, Quality Control, batch release, or pharmaceutical/manufacturing environments.
• Experience reviewing batch records, deviations, NOEs, and COAs.