Associate Stability Research Scientist II

Job Title: Associate Stability Research Scientist II
Location: 8368 Clayton Boulevard, Clayton, NC
Job Type: 12-Month Contract
Pay Rate: $25 $27/hour

Job Description
The Associate Stability Research Scientist II will provide scientific and technical support for the research and development of plasma-derived and recombinant proteins. This role supports the Stability Group by overseeing all aspects of the stability program related to stability chamber operations, sample storage, inventory management, documentation, and sample distribution. The position plays a key role in maintaining a compliant stability program for licensed products and developmental projects while ensuring the safety and quality of products.

Key Responsibilities
Maintain the daily inventory of active stability studies in compliance with GMP requirements by ensuring proper accountability, documentation, and delivery of stability samples.

Coordinate with the Packaging team to obtain samples for placement into the stability program.

Maintain label printers to ensure uninterrupted printing of stability labels.

Audit sample labeling and documentation for accuracy and GMP compliance.

Deliver stability samples for laboratory testing and coordinate with QC Sample Specialists and Stability Supervisors to resolve any discrepancies.

Inspect stability samples for any unusual characteristics before laboratory testing.

Track requests for additional stability samples.

Generate and review monthly pull schedules for all active stability studies.

Create work orders for preventive maintenance and repairs of stability incubators and related equipment to minimize the risk of product loss.

Ensure preventive maintenance activities are completed on schedule.

Verify compliance of completed stability test request forms.

Perform data check-in activities for laboratory results, when applicable.

Enter test data into the Stability System, SAP, and other stability databases.

Assist with filing and maintaining stability records.

Investigate and resolve GMP deviations related to sampling, labeling, and inventory management.

Remove completed study samples from inventory and complete all required documentation.

Initiate purchase orders and work orders for the Stability Group.

Coordinate shipment of samples between company sites.

Train Stability staff on sample handling and inventory procedures.

Perform daily inspections of stability incubators and freezers.

Investigate temperature excursions outside validated operating ranges.

Monitor chamber temperature and humidity trends daily and perform weekly, monthly, and annual reviews to ensure equipment remains compliant and potential issues are addressed proactively.

Required Skills & Qualifications
Strong understanding of ICH Guidelines and GMP regulations related to stability programs.

Excellent written and verbal communication skills.

Strong interpersonal skills with the ability to collaborate across multiple cross-functional teams.

Working knowledge of stability chamber operations and storage facility management.

Ability to assess the impact of deviations and implement effective corrective and preventive actions (CAPA).

Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.

Experience with the following systems is preferred:

ScienTek Stability System

SAP

Loftware Labeling Solutions

Intermec Printers

DeltaV Monitoring System

LabWatch

Maximo Management System

TempTale Monitoring Devices

Experience with visual inspection, vial integrity testing, and biological sample shipment.

Strong attention to detail, organizational skills, and the ability to perform basic calculations.

Ability to work independently with minimal supervision while contributing effectively within a team environment.

Maintain accurate, complete, and timely documentation.

Education & Experience
Candidates must meet one of the following qualifications:

Master's Degree in a relevant scientific field, or

Bachelor's Degree with 1 2 years of relevant experience, or

No degree with 5+ years of relevant experience.

Relevant experience should be in a scientific discipline and/or within a regulated pharmaceutical stability program.

Work Environment & Physical Requirements
Work is performed in a laboratory and/or clinical environment.

Potential exposure to biological materials, chemicals, and electrical equipment.

Personal protective equipment (PPE), including protective eyewear, garments, and gloves, is required.

Frequent sitting and neck bending (4 6 hours per day).

Standing and neck twisting (2 4 hours per day).

Occasional walking, bending, twisting, and squatting.

Frequent repetitive hand and finger movements requiring fine motor skills.

Ability to lift 15 30 lbs. regularly and up to 35 lbs. occasionally.

Ability to reach above and below shoulder height.

Vision requirements include color discrimination and corrected near/far vision.

Strong communication, analytical, and problem-solving skills.

Ability to manage multiple complex tasks in a dynamic environment with changing priorities.

This position directly supports the quality and integrity of licensed and developmental products stored within the Stability Program, representing assets valued in the millions of dollars.