Stability Coordinator

Position Summary

The Stability Coordinator will be responsible for managing the Stability program for the QC/R&D laboratories cution 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.

• 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.

• Direct Reports:
  None
• Indirect Reports:
  None

• Manufacturing Operations
• Formulations / Technical Operations

• None

• 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

• Experience with Stability Software such as Nova Tek, 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.

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

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