Associate Stability Research Scientist

Location: Clayton

Job Title:

Associate Stability Research Scientist IIJob Description

We are seeking a detail-oriented Associate Stability Research Scientist II to support the management and execution of a regulated pharmaceutical stability program. This role is responsible for maintaining stability sample inventory, coordinating testing activities, monitoring stability storage equipment, and ensuring compliance with GMP and regulatory requirements. The successful candidate will work cross-functionally with Quality Control, Packaging, Manufacturing, and other teams to support both commercial and development-stage products.

This position is ideal for candidates with experience in pharmaceutical, biotechnology, biologics, or regulated laboratory environments who enjoy combining laboratory operations, inventory management, compliance, and data review responsibilities.

Responsibilities

+ Maintain inventory of stability samples for active studies while ensuring accurate documentation and sample accountability.

+ Coordinate the acquisition, storage, tracking, and delivery of samples for stability testing.

+ Generate and review monthly stability testing schedules and support testing activities.

+ Remove samples and complete required documentation upon study completion.

+ Track and manage requests for additional stability samples.

+ Support shipment of biological samples between company locations.

+ Ensure all stability-related records, labels, and documentation are accurate, complete, and GMP compliant.

+ Review and issue testing documentation associated with stability studies.

+ Assist with filing and maintenance of stability records.

+ Conduct investigations and document resolutions related to sample, labeling, inventory, or compliance discrepancies.

+ Support deviation investigations and implementation of corrective and preventive actions (CAPAs).

+ Perform daily assessments of stability chambers, incubators, and freezers.

+ Monitor temperature and humidity trends to ensure storage conditions remain within validated ranges.

+ Investigate environmental excursions and determine potential impact on stability studies.

+ Generate work orders and coordinate preventive maintenance and repair activities for stability-related equipment.

+ Support ongoing compliance of stability storage systems through routine reviews and trending analyses.

+ Enter and maintain stability study data within validated databases and electronic systems.

+ Review laboratory data and assist with data reconciliation activities.

+ Support inventory tracking and reporting functions.

+ Initiate purchase orders and work orders to support department operations.

+ Train personnel on stability inventory and sample handling procedures.

+ Collaborate with QC, Manufacturing, Packaging, and other functions to ensure effective execution of stability activities.

+ Communicate findings, issues, and recommendations clearly through written and verbal communication.

Essential Skills

+ Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or another scientific discipline plus 1-2 years of relevant industry experience, OR Master's degree in a scientific discipline, OR equivalent combination of education and experience.

+ Experience working in a GMP-regulated pharmaceutical, biotechnology, biologics, or life sciences environment.

+ Understanding of ICH stability guidelines and GMP regulations.

+

Experience with sample management, laboratory operations, inventory control, or stability programs.

+ Strong attention to detail and organizational skills.

+ Ability to investigate issues, document findings, and implement corrective actions.

+ Strong written and verbal communication skills.

+ Proficiency with Microsoft Office applications.

Additional

Skills & Qualifications

+ Experience supporting pharmaceutical or biologics stability programs.

+ Familiarity with systems such as SAP, Stability management databases, Maximo, DeltaV, Lab Watch, Loftware Labeling Solutions.

+

Experience with biological sample shipment and chain-of-custody requirements.

+ Background in visual inspection, vial integrity testing, or sample handling.

+

Experience with environmental monitoring, equipment qualification, or trend analysis.

Work Environment

Work hours are Monday through Friday, from 7:30 AM to 4:00 PM.

Job Type & Location

This is a Contract position based out of Clayton, NC.

Pay and Benefits

The pay range for this position is $30.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability
- Health Spending Account (HSA) -…