Lead/Senior Labels Specialist- (Pharma/GMP)

Job Description

Job Description

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

This position oversees the production of specialized labels for use on client specific projects for clinical trials and to provide support in the Operations Department with a variety of professional assignments.

Your role at Clinigen :

• Oversee the production of clinical trial labels from approved label text proofs utilizing ink jet, tabletop thermal transfer printers, and label creation software
• Partners 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
• Partners with Project Managers to address and resolve concerns and questions raised by our clients
• Coordinates and executes label printing validation activities and internal audit responses
• Coordinates and partners with Labels team to update and schedule activities weekly
• Oversee and schedules all printing receiving and inspection of single panel
• Responsible for all activities involved with outsourced booklet labels
• Completes and files required paperwork for label group in a timely an accurate manner
• Partners with the Operations Department to maintain and update the clinical supplies label inventory including receive, count and document incoming and current label inventory and ancillary supplies
• Learns and adheres to Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and CSM’s Standard Operating Procedures (SOPs)
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures

Requirements

To be successful in this role you should have:

• High School Diploma or GED required; Associate’s Degree preferred

• 3+ years of experience within a GMP environment
• 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)

We’re excited about you if you have:

• Ability to work independently or within a team
• Detail oriented to produce timely and accurate work
• Familiar 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
• Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials preferred
• 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

While at Clinigen, you’ll enjoy:

The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.

The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.

The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

EEO. Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.