Quality Associate II

The primary responsibility of this position is to provide Quality Assurance and Quality Control activities to support Production. This role will also ensure compliance with all applicable regulatory mandates and/or customer specific requirements. Conduct audits, inspections, and investigations of routine to moderate complexity at various stages of production. Responsible for assisting with investigations into events involving non-conforming raw materials, finished product or goods, and deviations.

• In-process
• Line audits
• Start-ups and changeovers
• Finished Goods
• Trailers
• Incoming raw materials.
• GMP Audits
• Conduct initial research into nonconformances and process deviations as directed.
• Maintain cGMP compliant documentation of Production and Quality records.
• Maintain Chemical Inventory Management documentation and records.
• Maintain Incoming Raw Material documentation and records.
• Assist with Stability, Reserve, and USP Sampling Programs.
• Contribute to on-going review and update of written procedures and forms for alignment with current processes and draft their initial edits.
• Collect and report observations of systemic improvement opportunities.
• Review and approval for release of GDP and cGMP compliant Daily Batch Records and other Quality records.
• Identify and place any non-comforming material or products on Quality Hold. This will include physical placarding, quarantining and system Quality Holds.
• Assist with product returns and make appropriate notifications.
• Maintain cleanliness and organization of all Quality areas.
• Maintain Quality Hold Logs and the Disposition of products.
• Intermediate Data Entry (Logbooks, Spreadsheets, and ERP system)
• Assist Supervisor with maintaining Daily Compliance Logs.
• Will coordinate with training staff to educate employees on Good Manufacturing Practices, Good Documentation Practices, and Safety & Housekeeping Policies. Assist Production Supervisors and the Training Dept. with employee training.
• Maintain and organize Document/Record Storage.
• Train QA1 and other Quality Staff as needed.
• Report observations of unsafe working conditions to management.