Remote Qa Associate, Electronic Documentation Management (Sk1911)

Contract: 7 Months (Renewable)

Quality Assurance, Associate III
Job Summary
Client team is dedicated to making the right product quality decisions for the protection of our patients. The QA Associate III position is responsible for reviewing batch production records and associated documentation to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations.
Responsibilities:
• Review cGMP Controlled Documents such as master batch production records, test methods, and specifications. Manage implementation of required changes to meet GMP and internal standards.
• Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies with CMOs. Perform technical disposition activities.
• Review and provide input into internal and externally generated deviations. Track open deviations through to final closure.
• Support administrators of supplier qualification program in assessment of supplier changes and qualification.
• Assist with the collection, reporting and presentation of department metrics including Quarterly reports and Annual product reviews.
• Create and revise Standard Operating Procedures as needed.
• Participate in regulatory inspections.
• Represent QA and participate as QA lead on electronic system and process improvement sub teams as it pertains to External Quality processes
Qualifications and Education Requirements:
• Knowledge of cGMP and applicable FDA regulations
• Bachelor’s degree in a scientific discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
• Very detail oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Experience with electronic systems such as Electronic Documentation Management System (EDMS), Quality Management System (QMS), and ERP (Oracle)
• Strong computer skills with Word and Excel
• Ability to work effectively at a fast pace with cross functional departments
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to anticipate and mitigate challenges
• Experience supporting regulatory inspections desired