Stability Coordinator

Evolving Solution Services; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

The Stability Coordinator at Evolving Solution Services in Dallas, TX drives stability program execution within a GMP Quality Control environment. You will manage protocols, study initiation, sample laydown, timepoint pulls, and data collection to support shelf-life determinations and regulatory filings.

Onsite Monday–Friday, collaborate with internal teams and external labs, prepare reports, trend stability data, and participate in audits.

Qualifications

• Bachelor’s degree required in a scientific discipline.
• 2–4 years of QC or stability lab experience in a cGMP environment.
• Experience with stability program execution: drafting protocols, initiating studies, laydown and timepoint pulls.
• Knowledge of ICH guidelines (Q1A–Q1E), cGMP, FDA regulations, and lab documentation.
• Experience with data trending and drafting stability reports.

Responsibilities

• Draft, review, and maintain stability study protocols per ICH/FDA guidelines.
• Initiate stability studies for batches, registration lots, validation studies, and annual monitoring.
• Coordinate sample laydown into stability chambers and timepoint pulls.
• Manage clean stability chambers, chamber mapping, and logs.
• Prepare interim and final stability reports for shelf-life determinations and regulatory filings.
• Support investigations into OOS/OOT findings and CAPA initiatives.
• Serve as SME during internal audits/inspections for stability program oversight.

Education

Bachelor’s degree in Chemistry, Biology, Life Sciences, or related scientific/technical discipline

Tools

LIMS

Smartsheet

Excel

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Stability Coordinator

Full Time Professional Dallas, TX, US

6 days ago Requisition ID: 1016

JOB TITLE: Stability Coordinator DEPARTMENT: Quality Control

REPORTS TO : Quality Control Management EMPLOYEE STATUS: Exempt

LOCATION: Onsite Only – Monday-Friday WORK AVAILABLE: Full-Time

SUMMARY

TheStability 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), cGMP, 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
• Excellent organizational skills and detail-oriented record-keeping
• Effective cross-functional team and vendor communication