GMP Production Team Lead

Clinigen•Malvern, PA

1d•Onsite

About The Position

The primary purpose of the Production Team Lead is to lead the packaging team to package, label and accurately document the creation of clinical trial material. This position requires on-site presence 5 days/week.

Requirements

High School Diploma or GED required
6 months experience working within an office setting or medical field preferred.
6 months prior Clinigen packaging experience preferred.
Preferred experience with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), or Good Documentation Practices (GDP)
Ability to work independently or within a team.
Detail oriented to produce timely and accurate work.
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.
Excellent oral, written, and interpersonal communication skills with active listening ability.
Excellent time management skills to prioritize work and meet deadlines.
Ability to develop effective working relationships with associates at all levels to influence others and foster a cooperative work environment across the organization.

Responsibilities

Acts as lead to the packaging team by coordinating and directing the day-to-day tasks of the packaging team.
Supports the Packaging team by sharing knowledge, skills and information related to the tasks and requirements of the position.
Acts as a subject matter expert for the CEMS inventory system.
Acts as a subject matter expert on all primary packaging operations, including machine set ups and trouble shooting.
Makes proactive recommendations and present/offer solutions to improve quality and work efficiently.
Trains new packaging employees on packaging processes, procedures, and works with supervisor to ensure a mentor is assigned.
Performs all Packaging Specialist tasks and duties alongside other team members.
Provides support to their direct supervisor as needed.
Suggests improvements to processes and is a knowledge resource for other team members.