Full-Time SUMMARY The Stability Coordinator plays a key operational role within Quality Control in an FDA-regulated pharmaceutical environment. This position is primarily responsible for the overall execution, tracking, and oversight of the site's product stability testing programs. Key responsibilities include drafting stability protocols, initiating stability studies, managing sample laydown and timepoint pulls, compiling laboratory testing results, generating comprehensive stability reports, and performing continuous data trending to support regulatory filings and shelf-life assignments.
DUTIES & RESPONSIBILITIES
Stability Program Execution & Protocol Management Draft, review, and maintain stability study protocols in alignment with ICH guidelines, FDA regulations, and internal standard operating procedures (SOPs). Formally initiate stability studies for newly manufactured batches, registration lots, validation studies, and annual commercial monitoring. Coordinate and execute stability sample laydown into designated stability chambers under appropriate storage conditions (e.g., standard, accelerated, stress testing). Manage the execution of scheduled timepoint pulls according to protocol-defined windows and assign pulled samples to internal testing teams or external contract testing laboratories. Maintain clean, organized stability chambers, chamber mapping records, and environmental monitoring logbooks. Data Management, Trending & Reporting Collect, verify, and compile internal and external laboratory testing data across all stability timepoints. Prepare comprehensive interim and final stability reports to support product shelf-life determination, regulatory filings, annual product reviews (APRs), and regulatory submissions. Perform statistical data trending and analysis on stability test results to identify out-of-trend (OOT) results, shelf-life projections, and potential product degradation patterns. Utilize Laboratory Information Management Systems (LIMS), Smartsheet's, Excel, or dedicated data platforms for precise sample tracking, timepoint scheduling, and data entry. Quality & Compliance Support Initiate and support investigations into Out-of-Specification (OOS) findings, Out-of-Trend (OOT) results, chamber excursions, and deviations related to stability samples or storage conditions. Participate in CAPA execution, root cause analysis, and continuous improvement initiatives for the stability program. Serve as the Subject Matter Expert (SME) during internal audits and regulatory inspections (e.g., FDA) for stability testing program oversight, protocols, and reports. Coordinate sample shipments to external testing vendors, maintaining chain-of-custody tracking and ensuring complete data return.
REQUIRED QUALIFICATIONS
Bachelor's degree in Chemistry, Biology, Life Sciences, or a related scientific/technical discipline. 2-4 years of relevant Quality Control or Stability laboratory experience in an FDA-regulated cGMP environment. Direct hands-on experience with stability program execution, including protocol drafting, study initiation, sample laydown, and timepoint pulling. Strong working knowledge of ICH guidelines (Q1A-Q1E), c
GMP, FDA
regulations, and standard pharmaceutical laboratory documentation practices. Experience with data trending, statistical evaluation of stability data, and drafting formal stability reports. High attention to detail, exceptional organizational abilities, and strong written and verbal communication skills.
PRFERRED EXPERIENCE
Experience drafting SOPs and Product Specifications Experience drafting Stability study protocols and executing stability programs. Proficiency with data management platforms such as LIMS, Smartsheet's, Excel, or other relevant data systems. Prior experience coordinating external vendors and managing third-party testing shipments.
KEY COMPETENCIES
Stability program management (protocol drafting, laydown, timepoint pulls, reporting) Data trending, statistical evaluation, and reporting accuracy Strict adherence to regulatory compliance and ICH guidelines Robust investigation skills (OOS/OOT, chamber excursions, deviations) Excellent organizational skills and detail-oriented record-keeping Effective cross-functional team and vendor communication
