Job Description

Summary:

The QA Associate supports the Quality Assurance Manager in upholding the Quality Management System. Maintain product quality, cGMP and regulatory compliance requirements. Oversee compliance and support operations in manufacturing and warehouse on the second shift. Ensure adherence to company procedures. Support continuous improvement of the quality system.

Hours:

3:30 AM to 12:00 PM Monday through Friday

Extended hours during the week and Saturdays and Sundays may be required as necessary to support the business needs.

This is a 100% on-site job

Responsibilities:

• Batch record issuance and review
• Prepare and review documents for operations
• Review Certificate of Analysis
• Keep track of material status
• Author, revise and track status of Standard Operating Procedures (SOP’s)
• Write investigations and change controls
• Implement CAPA
• Conduct training
• Support internal audits
• Assist in customer and regulatory audits
• Compile information for Annual Product Reviews (APR’s)
• Schedule calibration/certification services
• Address customer requests and questionnaires
• Track vendor qualifications
• Data entry and collection
• Maintain data integrity
• Manage controlled documents
• Review shipment inspection forms
• Other duties assigned by Management

Education Requirements;

• Bachelor’s degree (science major preferred) with a minimum of 1 year experience in regulated, cGMP environment (pharmaceutical/manufacturing industry preferred)

Other Requirements:

• Excellent cGMP documentation skills
• Very high attention to detail
• Excellent organization skills
• Effective written and verbal communication skills
• Excellent interpersonal skills
• Must proficiently speak, read and write in English
• Ability to multi-task in a fast-paced environment
• Trustworthy; must maintain confidentiality
• Must be able to work in a collaborative environment with minimal supervision

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