Specialist/Sr. Specialist, CSO Packaging and Labeling

Working with Us
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Position Summary

The Senior Specialist, Clinical Supplies Packaging & Labeling is responsible for the execution and oversight of clinical label printing, inspection, and disbursement activities in a cGMP-compliant environment. This role applies thorough working knowledge of the clinical supply process and technical aspects of cGMP regulations as they relate to product packaging and labeling. The Senior Specialist supervises union hourly staff in packaging and labeling operations, conducts employee training, liaises with Quality Assurance, and drives continuous improvement initiatives — ensuring all production orders are executed in full compliance with regulatory requirements and departmental SOPs.

Key Responsibilities

• Demonstrate thorough working knowledge of the clinical supply process and the technical aspects of cGMPs as they relate to product packaging and labeling; apply this knowledge to day-to-day packaging and labeling activities that produce finished printed labels and packaged clinical supplies while ensuring and maintaining compliance with all quality requirements
• Review the master production schedule and label production orders; exhibit sound judgment in executing label print orders and label disbursement against required timelines
• Print clinical labels utilizing label print software and supervise union staff in the label inspection process; maintain label stock inventory
• Liaise with Quality Assurance to ensure release of both in-house and outsourced printed labels are approved, released, and available for disbursement against required timelines
• Supervise hourly staff, as required, in all aspects of packaging and labeling of clinical supplies
• Assure all production orders are executed in accordance with cGMPs and departmental SOPs; utilizing SAP, deliver complete, error-free technical documentation supporting packaging & labeling and label inspection production processes
• Develop and recommend improvements to facilities, equipment, or procedures to improve quality, safety, and efficiency
• Establish and support a work environment of continuous improvement that supports the Company's Quality policy, Quality Systems, and the appropriate regulations for the area
• Utilize technical writing skills to generate procedures and guidelines
• May participate on high-performing teams representing the global packaging organization as a subject matter expert
• Conduct training of new and existing employees on the label inspection process and ensure their training is documented
• Ensure that health and safety guidelines are followed; maintain cGMP/housekeeping at a high level within the department

Qualifications & Experience

Education:

• Bachelor of Science required; relevant experience may be considered in lieu of degree

Experience:

• 5+ years of experience in the pharmaceutical industry, preferably in pharmaceutical manufacturing with a focus on the production of Clinical Trial Supplies
• 3–5 years of progressive leadership or supervisory experience in the pharmaceutical industry required

Required Skills & Competencies:

• Prior supervision of production staff or leadership role within a production operation, with demonstrated ability in scheduling, organizing, and team building — required
• Working knowledge of Lean/Six Sigma tools and concepts: 5S, Kanban, Kaizen, Green Belt/Black Belt, etc.
• Working knowledge of cGMPs and regulatory requirements (FDA, EU, OSHA, etc.) and their application within a packaging and labeling production environment
• Solid record o