job summary: The Associate Stability Research Scientist is a dual-focus role. You will provide scientific expertise in the research and development of plasma-derived or recombinant proteins while simultaneously overseeing the daily operations of the Stability Program. This includes maintaining sample inventory, overseeing stability chamber areas, and ensuring the ongoing safety and quality of licensed and developmental products. location: Durham, North Carolina job type: Temporary salary: $37.50 - 43.00 per hour work hours: 8 to 4 education: Bachelors responsibilities: Analytical & Technical Science Method Development: Provide technical expertise in R&D utilizing separations-based analytical techniques (HPLC, CE, SDS-PAGE). Develop and qualify methods based on ICH guidelines. Data Management: Utilize Waters Empower (Essential) and Chromeleon to analyze data. Enter test data into stability databases and SAP. Visual Inspection: Perform visual inspection and vial integrity testing on samples. Stability Operations & Logistics Inventory Control: Maintain daily product inventory for active stability studies. Coordinate with Packaging to acquire batch samples and track requests for additional samples. Sample Management: Maintain and audit sample labeling (Loftware/Intermec printers). Facilitate delivery of samples to laboratories and coordinate with QC Sample Specialists. Chamber Maintenance: Perform daily assessments of stability incubators and freezers. Analyze temperature and humidity trends daily. Generate work orders for preventative maintenance to prevent product loss. Compliance & Quality Assurance Investigations: Conduct investigations for temperature excursions or GMP discrepancies associated with sampling or inventory. Ensure corrective actions (CAPA) are implemented and effective. Documentation: Review monthly pull schedules, ensure compliance of test request sheets, and assist with filing stability records. Regulatory: Maintain strict adherence to cGMP, GLP, and ICH guidelines. qualifications: Education & Experience Master's Degree: In a scientific field. Bachelor's Degree: In a scientific field + 1-2 years of relevant experience. No Degree: 5+ years of relevant experience (specifically for the Associate Stability Research Scientist II level). Experience must be in the regulated pharmaceutical industry within a stability program. Technical Systems & Software Lab Software: Waters Empower (Essential), Chromeleon (Desirable). Stability/Logistics Software: ScienTek Stability System, SAP, Loftware labeling solutions, DeltaV Monitoring System, LabWatch, Maximo Management System. Hardware: Intermec printers, TempTale Monitoring Devices. Key Competencies Calculations & Detail: Ability to perform basic calculations and possess keen assessment skills to note uncharacteristic properties of samples. Communication: Ability to communicate complex information and apply abstract principles to solve conceptual issues. Independence: Ability to carry out tasks independently with minimal supervision. Physical & Environmental Demands Environment: Work is performed in clinical/laboratory settings with potential exposure to biological fluids, infectious organisms, and chemicals. Physical: Moderate lifting of 15-30 lbs (max 35 lbs). Frequent sitting, bending neck (4-6 hours), and hand movements for fine manipulation. Vision: Color perception/discrimination required. Near/far vision correctable to 20/30 (one eye) and 20/100 (other eye). skills: Chromatography, Laboratory Information Management Systems (LIMS), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography (LC), Good Laboratory Practices (GLP), Capillary Electrophoresis (CE), Good Manufacturing Practices (GMP), International Council for Harmonization (ICH) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.