QA Specialist

Snelling Staffing DFW; Fort Worth (TX); Sur place; USD 34 000 - 37 000; Plein temps

Résumé du poste

Snelling Staffing DFW seeks a detail-oriented QA Specialist - Batch Release to support QA and batch release activities in a GMP environment. You will review batch documentation, prepare quality documentation, approve raw materials, release materials in SAP, and liaise with clients on quality matters.

The role emphasizes accuracy, timely QA decisions, and cross-functional collaboration to ensure compliant batch releases.

Qualifications

• Experience in a GMP-regulated environment.
• Strong technical writing skills.
• Proficiency with Microsoft Excel.
• Excellent attention to detail and organizational skills.
• Ability to review detailed documentation and identify discrepancies.
• Strong written and verbal communication skills.
• Ability to work independently while coordinating with cross-functional teams.
• Customer-service mindset when engaging with clients.

Responsabilités

• Review and approve batch records to ensure GMP compliance.
• Prepare and document deviations, NOEs, and other quality docs.
• Release materials and complete SAP transactions daily.
• Review and approve raw materials and COAs.
• Maintain QA records and documentation.
• Communicate with clients regarding quality and batch release matters.
• Provide professional customer service and timely responses.
• Collaborate with Production, Quality Control, and Operations to resolve issues.

Connaissances

Technical writing

Attention to detail

Written and verbal communication

Customer service mindset

Outils

SAP

Microsoft Excel

Description du poste

• 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.