Job Description
Job Description
- 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.