QA Specialist (Batch Record Reviewer)

📋 Description

• Performing the Quality Assurance review and release of semi-finished product, validation, media
• Review batch records to support product release schedule, ensuring regulatory compliance, customer
• Quarantine and monitor product in 'on hold' status prior to disposition.
• Prepare required batch disposition documentation and provide to international markets as required
• Identify and resolve all batch record discrepancies to prevent a regulatory impact.
• Assist department supervisors in maintaining dispositioned batch records to provide an efficient

🎯 Requirements

• Bachelor's Degree in the Sciences or technical field or equivalent experience.
• 5 years of experience in a quality role or experience handling and reviewing documentation records.
• Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
• 3 years of experience in a GMP Environment.
• Prefer experience in an aseptic manufacturing environment.
• Working knowledge of Quality Assurance systems, cGMP's, ISO 13485, CMDRs, and EMEA regulations

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs