Description 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.

Requirements Knowledge & Skills:

Strong knowledge of pharmaceutical cGMPs and Quality Systems. Working knowledge of FDA and DEA requirements applicable to pharmaceutical manufacturing, packaging, warehousing, and distribution. Knowledge of secondary packaging, labeling, line clearance, batch documentation, inventory control, shipping, returns, and product traceability. Experience with deviations, NCRs, CAPAs, investigations, and root cause analysis. Strong written, verbal, technical writing, analytical, and problem-solving skills. Strong attention to detail and organizational skills. Ability to supervise, coach, train, motivate, and hold employees accountable. Ability to work independently, manage multiple priorities, and make sound decisions. Strong cross-functional communication and teamwork skills. Proficiency with Microsoft Word, Excel, and PowerPoint. Experience with electronic Quality Management Systems preferred. Ability to adapt to changing business and operational priorities while maintaining compliance.

Education/Experience:

Bachelor's degree in a scientific, technical, pharmaceutical, engineering, or related field preferred; High School Diploma or GED required. Minimum 3 years of pharmaceutical Quality Assurance/Quality Operations experience. Secondary packaging, manufacturing, warehouse, distribution, or finished goods experience preferred. Minimum 3 years supervisory or lead experience in a GMP environment. Experience with deviations, investigations, CAPA, audits, and GMP documentation. 2-3 years of experience with Microsoft Word, Excel, and PowerPoint. 1-2 years of project management, coordination, or process improvement experience preferred.

Work Conditions/ Physical Requirements:

Position requires lifting (up to 50 lbs.), vision (20/20) corrected with glasses or contacts and standing (10%), sitting (40%), walking (50%), talking, typing and hearing. Incumbents are required to wear specified protective equipment as necessary.