Job Purpose:
The Assistant Manager, Quality Operations, Secondary Packaging & Warehouse provides Quality oversight and leadership for secondary packaging, finished goods warehousing, shipping, returns, and related Quality Operations activities. This position ensures compliance with current Good Manufacturing Practices (cGMP), FDA/DEA requirements, company procedures, and established Quality Systems. The position provides day-to-day Quality support and direction to packaging and warehouse operations, promotes a culture of quality and continuous improvement, and supports the timely identification, investigation, documentation, and resolution of quality issues.
Essential Duties and Responsibilities:
- Provide Quality oversight and direction for secondary packaging, warehouse, finished goods, shipping, returns, and retain operations.
- Ensure compliance with cGMPs, FDA/DEA requirements, SOPs, safety requirements, and applicable Quality Systems.
- Monitor packaging operations, line clearances, component accountability, labeling, reconciliation, documentation, and housekeeping to prevent errors, mix-ups, and contamination.
- Review and approve batch records and related GMP documentation for accuracy, completeness, and compliance.
- Support and/or lead deviations, NCRs, investigations, CAPAs, root cause analysis, audits, and other Quality System activities.
- Identify recurring quality issues and assist in developing and implementing effective corrective and preventive solutions.
- Review, revise, and assist in the development of SOPs, forms, specifications, and other GMP documentation.
- Maintain current knowledge of applicable FDA, DEA, cGMP, and Quality System requirements and communicate changes to affected personnel.
- Coordinate and conduct GMP training and retraining for Quality Operations personnel and ensure required training remains current.
- Provide coaching, direction, and support to Quality Operations personnel and promote accountability, teamwork, and a strong quality culture.
- Support validation, qualification, manufacturing/packaging studies, process improvements, and special projects as assigned.
- Provide Quality oversight during lot and batch changeovers, including line clearance, documentation, component reconciliation, and product accountability.
- Escalate significant deviations, mislabeling, product safety concerns, GMP deficiencies, and non-conformances to the Quality Operations Senior Manager or designee.
- Provide Quality oversight of finished goods picking, packing, staging, loading, and shipping to ensure product integrity, accuracy, and compliance.
- Perform random shipment verifications and review finished goods cycle counts and inventory audits, including controlled and non-controlled substances, as applicable.
- Ensure finished goods are stored in accordance with FDA, DEA, company, and applicable environmental and security requirements.
- Oversee product returns, including evaluation, segregation, documentation, and disposition in accordance with approved procedures.
- Manage Finished Good Retains, including inventory, identification, storage, organization, and disposition.
- Verify and oversee appropriate documentation and disposition of applicable waste.
- Assist with product shipping studies and transportation-related activities.
- Manage assigned Dot records and ensure Quality System activities are completed accurately and timely.
- Communicate quality observations, discrepancies, trends, and compliance concerns to management in a timely manner.
- Assist Quality management with additional duties, projects, and responsibilities as required.
