Stability Coordinator

MedPharm•Durham, NC

About The Position

The Stability Coordinator will be responsible for managing the Stability program for the QC/R&D laboratories at MedPharm. Execution of the stability program includes initiating stability protocols, stability inventory schedules, stability pulls, ensuring timely testing of products, compiling stability reports, and trending data across the shelf-life of multiple products. In this role, the candidate will collaborate with other departments and manage multiple projects with a commitment to Safety, Quality, and Customer Service.

Requirements

B.S with 4-6 years experience, or M.S with 2-3 years of experience.
2-5 years´ experience in a GMP laboratory setting in the pharmaceutical industry
Experience managing a stability program
Good understanding of Ph. Eur/USP/NF, FDA Good Manufacturing Practices Regulations (GMP’s) and OSHA safety requirements.
Knowledge and experience in a cGMP environment, preferably topical pharmaceuticals
Knowledge of cGMPs, USP, and FDA (21 CFR Parts 210 and 211) regulations related to managing the stability program
Strong documentation skills, with great attention to detail
Strong critical thinking and troubleshooting skills
Strong reading comprehension and listening skills.
Ability to multitask and work under minimal supervision
Excellent work ethic and time management skills.
Excellent oral and written communication skills
Strong computer skills (Microsoft Office)
Good organization skills with the ability to adapt to changing business priorities
Proficient in principles of data integrity
Highly motivated individual, who fosters collaboration and teamwork
Able to work overtime.
Have strong Interpersonal, Facilitative, and Organizational skills.
Effectively interacts with multiple functions and diverse individuals to achieve goals.
Demonstrates excellent decision-making skills and the ability to prioritize appropriately.
Able to work independently with minimal supervision.

Nice To Haves

Knowledge of analytical laboratory instrumentation is preferred
Experience with Stability Software such as NovaTek, Scientek, SLIMS, etc.

Responsibilities

Author stability protocols prior to the initiation of the stability study
Collaborate with QC, QA, Program Management, and / or AR&D to identify products, testing criteria and type of stability studies required
Initiate and track stability sample requests per company procedures
Receive and document stability samples into the respective inventory schedules
Create stability pull lists for each month, depending on the type of stability study
Perform timely pulls of stability samples and track timely completion of all stability projects
Perform testing of stability samples as needed
Perform periodic inventory check of stability chambers.
Review stability data to ensure that testing and documentation is performed according to company procedures
Compile analytical data into stability reports and trend the data over the shelf-life of the products
Identify and report any out of trend or out of specification data to laboratory management
Assist laboratory management with investigations related to stability studies
Support Quality Assurance by providing stability data for submission of regulatory documents
Coordinate testing with outside laboratories, including obtaining quotes, generating purchase requisitions, shipping paperwork and required documentation.
Reconciling invoices with work performed.
Maintain cGMP principles and Good Documentation practices.