Lead Labels Technician - (Pharma/GMP)

About the role

Oversee the production of specialized labels for client-specific projects for clinical trials and provide support in the Operations Department with a variety of professional assignments.

• Oversee the production of clinical trial labels from approved label text proofs utilizing ink jet, tabletop thermal transfer printers, and label creation software.
• Partner with Project Managers to prioritize, coordinate, and maintain labeling projects and printing production schedules, as well as monitor the approval cycle of label projects to provide guidance to Label Associates.
• Partner with Project Managers to address and resolve concerns and questions raised by clients.
• Coordinate and execute label printing validation activities and internal audit responses.
• Coordinate and partner with the Labels team to update and schedule activities weekly.
• Oversee and schedule all printing, receiving, and inspection of single-panel labels.
• Responsible for all activities involved with outsourced booklet labels.
• Complete and file required paperwork for the label group in a timely and accurate manner.
• Partner with the Operations Department to maintain and update the clinical supplies label inventory, including receiving, counting, and documenting incoming and current label inventory and ancillary supplies.
• Learn and adhere to Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and CSM's Standard Operating Procedures (SOPs).
• Follow, promote, and enforce relevant SOPs, Job Aids, and Company policies and procedures.

Requirements

• High School Diploma or GED required; Associate's Degree preferred.
• 2 to 4 years of related work experience within an office setting.
• Working knowledge of GMP directives and FDA guidelines.
• Preferred: 1 year of experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP).

Skills

• Ability to work independently or within a team.
• Detail-oriented to produce timely and accurate work.
• Familiarity with the tools, concepts, and methodologies of label design (graphics) and printing desired.
• Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials preferred.
• Excellent oral, written, and interpersonal communication skills with active listening ability.
• Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast-paced environment.
• Maintain a high regard for confidentiality while dealing with all clients, proprietary, and pharmaceutical-related information.
• Highly computer literate; experience operating with all Microsoft Office software.

Benefits

• Inclusive company culture that values diversity and engagement.
• Transparency with leadership, including anonymous feedback opportunities through an employee engagement platform.
• A broad range of activities, systems, and programs providing competitive benefits and celebrating success.