Stability & Quality Control Specialist

Mark Cuban Cost Plus Drug Company, PBC; Town of Texas (WI); On-site; USD 70,000 - 100,000; Full time

Job summary

Mark Cuban Cost Plus Drug Company, PBC in Wisconsin seeks a detail-oriented Stability Coordinator to oversee product stability programs in an FDA-regulated cGMP environment. You will draft protocols, initiate studies, manage sample laydown, and track results across timepoints.

You will prepare interim and final stability reports, trend data, support regulatory filings, audits, investigations of OOS/OOT, and collaborate with QA, manufacturing, and external labs.

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, including Q1A through 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, including the ability to prepare technical reports and coordinate with internal and external 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.

Responsibilities

• Draft, review, and maintain stability study protocols in accordance with ICH guidelines, FDA regulations, and internal SOPs.
• Initiate stability studies for manufactured batches, registration lots, validation studies, and annual commercial monitoring.
• Coordinate stability sample laydown in designated chambers under required storage conditions, including standard, accelerated, and stress conditions.
• Manage scheduled stability timepoint pulls within protocol-defined windows and assign samples to internal laboratories or external testing vendors.
• Maintain organized stability chambers, chamber maps, environmental monitoring records, and associated logbooks.
• Collect, verify, compile, and track laboratory testing results from internal and external laboratories across all stability timepoints.
• Prepare interim and final stability reports supporting shelf-life determinations, regulatory filings, annual product reviews, and regulatory submissions.
• Perform statistical trending and analysis of stability data to identify out-of-trend results, degradation patterns, and shelf-life projections.
• Use LIMS, Smartsheet, Excel, or similar systems to manage sample tracking, schedules, timepoints, and data entry.
• Support investigations related to OOS and OOT results, chamber excursions, deviations, and stability sample issues.
• Participate in CAPA activities, root cause analysis, and continuous improvement initiatives for the stability program.
• Serve as a stability program subject matter expert during internal audits and regulatory inspections.
• Coordinate shipments to third-party testing laboratories, maintain chain-of-custody documentation, and ensure complete and timely data return.
• Collaborate effectively with Quality Control, Quality Assurance, manufacturing, regulatory, and external laboratory partners.

Skills

Quality Control

Stability programs

Data trending

Statistical evaluation

Documentation

Cross-functional collaboration

OOS/OOT investigations

Education

Bachelor's degree in Chemistry, Biology, Life Sciences, or related field

Tools

LIMS

Smartsheet

Excel

Job description

Mark Cuban Cost Plus Drug Company, PBC in Wisconsin seeks a detail-oriented Stability Coordinator to oversee product stability programs in an FDA-regulated cGMP environment. You will draft protocols, initiate studies, manage sample laydown, and track results across timepoints.

You will prepare interim and final stability reports, trend data, support regulatory filings, audits, investigations of OOS/OOT, and collaborate with QA, manufacturing, and external labs.