Sr. Associate Stability Research Scientist I

Grifols•Clayton, NC

About The Position

The incumbent provides scientific and technical support for research and development of plasma-derived or recombinant proteins. The role supports the Stability Group by overseeing stability chambers and managing the storage, delivery, and documentation of sample inventory. This work helps maintain a compliant stability program for licensed products and developmental projects and supports product safety and quality. The position manages daily inventory and documentation for active stability studies, coordinates sample acquisition and laboratory testing, maintains labeling equipment and records, and enters and reviews stability data. It also supports equipment maintenance, chamber monitoring, audits, investigations, and corrective actions. For the M06 position, the incumbent is the primary contact for chamber alarms around the clock and coordinates timely responses, including potential relocation of samples. The role also supports audits, equipment calibration and validation, staff training, and reporting on chamber activities.

Requirements

Relevant education and experience: a master's degree plus 1 year of experience, a bachelor's degree plus 3–4 years of experience, or no degree plus 7 years of experience.
Education or experience must be relevant, such as a scientific-field college degree and/or experience in the regulated pharmaceutical industry in a stability program.
Understanding of ICH guidelines and regulatory-agency GMP requirements relating to storage of stability product.
Strong written and oral communication skills for producing clear, accurate, and logical reports and interacting effectively with all organizational levels and cross-functional teams.
Working knowledge of equipment and storage-facility operations and ability to resolve chamber-related problems quickly.
Ability to assess the impact of deviations on the stability program and ensure corrective actions are implemented and effective.
Working knowledge of word-processing, spreadsheet, and email programs.
Required training and working knowledge of ScienTek Stability System, Loftware labeling solutions software, Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System, and TempTale Monitoring Devices.
Experience with visual inspection, vial integrity testing, and shipment of biological samples.
Ability to perform basic calculations, with keen assessment skills and extreme attention to detail.
Experience creating or revising SOPs.
Ability to maintain neat, accurate, complete, and timely records.
Initiative and willingness to learn.
Ability to work independently or with minimal supervision and function in a team environment.

Responsibilities

Maintain daily product inventory for active stability studies and ensure accountability, delivery, and documentation of samples and testing requests.
Coordinate with Packaging to obtain samples for batches entering the stability program.
Maintain label printers and audit sample labels and documentation for accuracy and GMP compliance.
Deliver stability samples for laboratory testing and coordinate with QC Sample Specialists and Stability supervisors to resolve discrepancies.
Assess samples for uncharacteristic properties before they are sent to laboratories.
Track requests for additional samples and generate and review monthly stability-testing pull schedules.
Generate preventative maintenance and repair work orders for stability incubator equipment and ensure the preventative maintenance program is completed on time.
Assure compliance of completed Stability test request sheets, as applicable.
Check in stability data received from testing laboratories and enter test data into the Stability System and/or SAP.
Assist with filing Stability records and remove samples from inventory when studies are complete, performing required documentation.
Conduct investigations and document and resolve GMP discrepancies associated with sampling, labeling, or sample inventory.
Initiate purchase orders and work orders for the Stability Group and ship samples between sites.
Train Stability staff on sample handling and inventory procedures.
Perform daily operational assessments of stability incubators and freezers.
Investigate excursions outside validated temperature ranges and analyze chamber temperature and humidity trends daily.
Perform weekly, monthly, and annual equipment reviews to confirm compliance and identify chamber concerns before studies are affected.
For the M06 position, serve as the primary 24/7 contact for chamber alarms, implement action plans, notify management, and lead cross-functional responses to protect stability studies and product quality.
For the M06 position, organize sample moves as needed and assist the supervisor with planning weekly activities and conducting weekly audits of Stability areas for GMP and safety items.
For the M06 position, report audit findings to management and follow up on corrective actions; participate in investigations related to GMP discrepancies.
For the M06 position, conduct weekly audits of stability equipment logbooks and temperature charts.
For the M06 position, act as the primary contact with Instrumentation and Validation for stability equipment calibration and validation, and issue equipment logbooks.
For the M06 position, author monthly reports on chamber activities and track and trend activity to assess workload and resource needs.