Stability Program Lead - QC & Regulatory Compliance

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

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.