• Issue, track, and maintain controlled documents in accordance with document control procedures
• Scan, file, and organize quality and production documentation to ensure full traceability
• Support data entry and maintenance of quality trending logs and quality system metrics
• Perform detailed, realtime review of batch records for accuracy, completeness, and GMP compliance
• Continuously review production logs and documentation for proper entries and adherence to procedures
• Provide floor support to Operations to ensure batch records are completed correctly and consistently
• Work within ISO Class 8 cleanroom environments following proper gowning procedures
• Follow all safety procedures when working in controlled environments involving hazardous drug products
• Identify documentation discrepancies and escalate issues promptly to the Quality team
• Draft and support deviation reports, including initial documentation, rootcause identification, and corrective/preventive action tracking
• Assist with investigation reporting to ensure timely closure and compliance with internal and regulatory expectations
• Maintain organized, compliant, and auditready documentation practices at all times

• Experience in Quality Assurance, documentation review, deviation writing, or GMP compliance within pharmaceutical, biotechnology, or other regulated manufacturing environments preferred
• Familiarity with GMP documentation practices, batch record review, and quality systems
• Strong attention to detail, accuracy, and organizational skills
• Ability to manage and review documentation efficiently in a fastpaced production environment
• Comfortable working in cleanroom environments and following gowning procedures

• $27.00 – $32.00 per hour, depending on experience

• 1st Shift, 8:30 AM – 5:00 PM
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