PLS GMP Stability Coordinator

Pace® Analytical Services•Oakdale, MN

1d•$75,000 - $85,000•Onsite

About The Position

This is a full-time, onsite, GMP Stability Coordinator position located in Oakdale, MN, Monday through Friday, 8:00 a.m. - 5:00 p.m. Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

Requirements

Bachelor's degree in chemistry, biology, environmental sciences, or a closely related field; AND one to two (1-2) years of technical or administrative support experience; OR an equivalent combination of education, training, and experience.
Understanding of the oversight of stability programs, policies, and procedures
Understanding of various testing tools, equipment, and calibration
Understanding of GMP, GLP and GDP requirements
Understanding of applicable laws, codes, and regulations
Methods to communicate with staff, coworkers, and clients to ensure safe, effective, and appropriate operations
Correct business English, including spelling, grammar, and punctuation
Training others in policies and procedures related to the work
Serving as a team member assisting with the development and management of projects
Operating in environments as an individual and with a team
Preparing fundamental functional reports, correspondence, and other written materials
Using initiative and independent judgment within established department guidelines
Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of work

Responsibilities

Ensure the accurate execution of the stability program for all assigned products.
Understanding of stability protocols describing materials, storage conditions, test methods, and study duration.
Ensure samples are pulled in a timely manner, properly distributed, and maintain compliant storage conditions.
Monitor for significant change and/or trends observed in the stability report and notify clients and management of these changes.
Maintain stability sample inventory and organization and cleanliness of stability chambers, coordinate sample shipments and coordinate sample submissions with outside testing laboratories.
Input data or facilitate its input into stability database, Laboratory Information Management Systems (LIMS) as it is generated.
Assists with projects involving verification of accurate check-in of samples; may provide response to client inquiries, and invoicing clients, as determined by the supervisor.
Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
Promotes and supports the overall mission of PLS by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.