Stability Coordinator

Position Summary –

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.

Essential Functions

• 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.

Supervisory responsibilities :

• Direct Reports: None
• Indirect Reports: None

Key Relationships:

• Manufacturing Operations
• Formulations / Technical Operations

Travel requirements :

• None

Education and Experience

• 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

Knowledge, Skills, and Abilities

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

​​​​​​ Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires constant standing, walking, seeing, gripping, & hearing
• Requires frequent sitting, bending, & reaching
• Requires constant carrying, frequently under 20 LBs, occasionally 20-60 LBS
• Requires frequent lifting, pushing, & pulling under 20 LBS, occasionally 20-60 LBS, & occasionally pushing & pulling over 60 LBS
• Requires occasional twisting

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.