Job 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.