Sr. Associate Stability Research Scientist I

GRIFOLS, S.A.•NC-Clayton, CA

10d

About The Position

The Sr. Associate Stability Research Scientist I provides scientific and technical support for research and development of plasma-derived or recombinant proteins. The role supports the Stability Group by overseeing stability chamber areas, storage, delivery, and documentation of sample inventory to maintain a compliant stability program for licensed products and developmental projects and support the ongoing safety and quality of products. For the M06 position, the incumbent is also the primary contact for chamber alarms, including coordinating a response and notifying management, and may organize off-shift sample relocations. The role assists the supervisor with activity planning and audits, serves as the primary contact with Instrumentation and Validation for stability equipment calibration and validation, and authors monthly chamber activity reports.

Requirements

A relevant MS degree plus 1 year of experience, a relevant BS degree plus 3–4 years of experience, or no degree plus 7 years of experience.
Relevant education in a scientific field and/or experience in the regulated pharmaceutical industry in a stability program.
Understanding of ICH guidelines and regulatory GMP requirements for stability product storage.
Strong written and oral communication skills, including the ability to prepare clear, accurate, and logical reports.
Excellent interpersonal and communication skills to work effectively with all organizational levels and cross-functional teams.
Working knowledge of equipment and storage facility operations and the ability to resolve chamber-related problems promptly.
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.
Training and working knowledge of ScienTek Stability System, Loftware labeling solutions, Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System, and TempTale Monitoring Devices.
Experience with visual inspection and vial integrity testing.
Experience shipping biological samples.
Ability to perform basic calculations, keen assessment skills, and extreme attention to detail.
Experience creating or revising SOPs.
Ability to maintain neat, accurate, complete, and timely records.
Demonstrated initiative and willingness to learn.
Ability to work independently or with minimal supervision and function in a team environment.

Responsibilities

Maintain daily inventory for active stability studies, including accountability and delivery of samples and associated documentation, and issue required documentation for testing.
Coordinate with Packaging to obtain samples for batches entering the stability program.
Maintain label printers in working order.
Maintain 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 stability samples for uncharacteristic properties before sending them to the laboratory.
Track requests for additional samples.
Generate and review monthly pull schedules for stability testing across active studies.
Generate work orders for preventive maintenance and repairs of stability incubator equipment and ensure preventive maintenance is completed on time.
Ensure completed stability test request sheets comply with requirements, as applicable.
Check in stability data received from testing laboratories, when applicable.
Enter test data into the Stability System and/or SAP databases.
Assist with filing Stability records.
Investigate and document GMP discrepancies related to sampling, labeling, or sample inventory, and resolve them.
Remove samples from inventory and complete required documentation when stability studies are completed.
Initiate purchase orders and work orders for the Stability Group.
Ship samples between sites.
Train Stability staff on sample handling and inventory procedures.
Assess the operation of stability incubators and freezers daily.
Investigate excursions outside validated temperature ranges for stability incubators.
Analyze stability chamber temperature and humidity trends daily and conduct weekly, monthly, and annual reviews to identify and address equipment concerns before studies are affected.
For the M06 position, serve as the primary contact for chamber alarms 24/7, implement action plans, notify management, coordinate interdepartmental responses, obtain necessary approvals, and organize sample relocations when required to protect product quality.
Assist the supervisor in planning weekly activities.
Assist the supervisor with weekly GMP and safety audits of stability areas, report findings to management, and follow up on corrective actions.
Conduct weekly audits of logbooks and temperature charts for all stability incubators.
Assist with information needed for chamber activities.
Serve as the primary contact with Instrumentation and Validation for calibration and validation of stability equipment.
Issue logbooks for Stability equipment.
Author monthly reports on chamber activities and track and trend activities to assess workload and resource needs.