The Stability Analyst III will be responsible for assisting in the management of the company’s stability ongoing commercial stability program. Responsibilities also include managing samples from initiation to delivery and providing ongoing management of the stability storage. The Stability Analyst III will be responsible for raw data review, entry of data into the trend tables, analyzing the data for any stability trends and alert of any possible OOT/OOS. Will assist in the setup, conditioning, transportation and documentation of stability samples. Responsibilities also include scheduled pulls and maintaining accurate records of on-going stability studies.
Responsibilities:
Maintain ongoing commercial stability program and assist with registration, clinical, and development stability studies. Includes monitoring stability requirements and ordering samples from Operations for inclusion into the stability program
Review raw and final commercial stability data to ensure complete and proper documentation according to applicable procedures and cGMPs
Enter and review stability data tables
Responsible for execution of stability protocols
Assist as required in the generation and review of interim and final stability reports or protocols
Trending of all stability data and alert management of any OOS or OOT values
Collaborate in OOS investigations or OOT investigations for stability studies
Ensuring that all chemical and microbiology tests associated with drug product stability studies are completed per approved SOPs
Client management with multiple clients/projects
Assist with leachable testing
Assist in special projects as requested by the manager
Oversee the initiate / terminate studies, and disposal processes. Ensure that new studies have been properly labeled, stored in the appropriate conditions and orientation. Ensures that stability studies are complete, data summarized and appropriate authorization has been obtained prior to sample disposal.
Coordinate transportation of the stability samples to Columbia facility and/or external labs
Assist in maintaining stability calendar
Follow Standard Operating Procedures, safety, health, and cGMP Guidelines
Travel Requirements:
Must be able to travel between TRC Main and TRC Parkway locations
Must have a valid driver’s license
Qualifications:
BS in Chemistry or related scientific field
A minimum of 3 years of analytical experience in a GMP laboratory or research setting
A minimum of 2 years of stability experience with testing and specifications requirements
Working knowledge of regulatory guidance’s for stability storage and testing
A minimum of 2 years of experience in stability programs
Technical writing experience in SOP, Regulatory submissions and technical reports