PLS GMP Stability Coordinator

About the role

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.

Responsibilities

• Ensure the accurate execution of the stability program for all assigned products.
• Understand 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.
• Aids 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.

Qualifications

• Education and Experience: 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.
• Required Knowledge and Skills: 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 preferred; 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.
• Required Skills: 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.

Physical/Mental Requirements

• Work requires mobility in both laboratory and office settings, including the ability to sit and stand frequently throughout the workday and to utilize a full range of motion for tasks such as reaching, bending, and handling materials.
• May require use of standard laboratory and office equipment and the ability to remain stationary for extended periods when needed.
• The position may involve exerting up to 20 pounds occasionally and/or up to 10 pounds frequently to move objects.

Benefits

Benefits include competitive salaries, medical, dental, vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer: Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws.