Pharma Stability Coordinator - Quality Control & Compliance

Mark Cuban Cost Plus Drug Company, PBC; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Mark Cuban Cost Plus Drug Company, PBC is seeking a detail-oriented Stability Coordinator to oversee product stability testing programs in a cGMP environment. You will draft protocols, initiate studies, manage sample laydowns, and analyze stability data to support shelf-life determinations and regulatory filings.

The role requires 2–4 years in QA or stability labs, knowledge of ICH guidelines, and experience with LIMS/Smartsheet/Excel.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related scientific or technical discipline.
• 2–4 years of relevant Quality Control or stability laboratory experience in an FDA-regulated cGMP environment.
• Hands-on experience executing stability programs, including protocol drafting, study initiation, sample laydown, and timepoint pulls.
• Working knowledge of ICH stability guidelines (Q1A–Q1E), cGMP requirements, FDA regulations, and pharmaceutical documentation practices.
• Experience trending stability data, conducting statistical evaluations, and preparing formal stability reports.
• Strong attention to detail, organization, documentation, and record-keeping skills.
• Clear written and verbal communication skills for technical reports and coordination with stakeholders.
• Ability to support investigations involving OOS, OOT, deviations, and stability chamber excursions.
• Experience using LIMS, Smartsheet, Excel, or comparable data-management and sample-tracking systems.
• Preferred: Experience drafting SOPs and product specifications.
• Preferred: Experience coordinating external testing vendors and third-party sample shipments.

Responsibilities

• Draft, review, and maintain stability study protocols per ICH guidelines, FDA regulations, and SOPs.
• Initiate stability studies for batches, registration lots, validation studies, and annual monitoring.
• Coordinate stability sample laydown in chambers under storage conditions (standard, accelerated, stress).
• Manage stability timepoint pulls within protocol-defined windows and assign samples to labs or vendors.
• Maintain stability chambers, maps, environmental records, and logbooks.
• Collect, verify, and track testing results from internal/external labs across all timepoints.
• Prepare interim and final stability reports for shelf-life determinations and regulatory filings.
• Perform statistical trending and analysis to identify out-of-trend results and shelf-life projections.
• Use LIMS, Smartsheet, Excel for sample tracking and data entry.
• Support investigations related to OOS/OOT, excursions, deviations, and stability issues.
• Participate in CAPA, root cause analysis, and continuous improvement of the stability program.
• Serve as SME during internal audits and regulatory inspections.
• Coordinate shipments to third-party labs and ensure data return with chain-of-custody.

Skills

Attention to detail

Organizational skills

Technical documentation

Communication skills

Problem-solving

Team collaboration

Auditing readiness

Education

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

Tools

LIMS

Smartsheet

Excel

Job description

Mark Cuban Cost Plus Drug Company, PBC is seeking a detail-oriented Stability Coordinator to oversee product stability testing programs in a cGMP environment. You will draft protocols, initiate studies, manage sample laydowns, and analyze stability data to support shelf-life determinations and regulatory filings.

The role requires 2–4 years in QA or stability labs, knowledge of ICH guidelines, and experience with LIMS/Smartsheet/Excel.