Associate Stability Research Scientist II

GRIFOLS, S.A.

22h•$85,115 - $100,000•Onsite

About The Position

The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring on-going safety and quality of our products.

Requirements

Bachelors Degree or Masters Degree with 1 to 2 years’ experience. Or, no degree with 5 plus years’ experience. Educational degrees and experience must be relevant to the position, i.e. college degree with emphasis in a scientific field and/or experience in the regulated pharmaceutical industry in a stability program.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Maintains Stability chamber facilities in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Primary contact for addressing chamber alarms (24/7). Responsible for carrying out the implementation of a plan of action for addressing chamber alarms and notification to Stability management. Organizes the movement of Stability samples while maintaining the product quality.
Must have organizational skills and ability to prioritize personal tasks to meet deadlines.
Must have strong and effective written and oral communication skills.
Demonstrates knowledge in area of specialization.
Proficient with the use of MS Office software.

Nice To Haves

An understanding of International Conference of Harmonization (ICH) guidelines and requirements set forth by regulatory agencies associated with the storage of Stability product is strongly preferred.

Responsibilities

Daily, maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability samples and associated documentation as well as the issuance of required documentation for testing.
Coordinate with Packaging to acquire samples for batches to be placed into the stability program for evaluation.
Maintain label printers in good working order to ensure ability to fulfill printing of labels for stability requests.
Maintain and audit all sample labeling and documentation for accuracy and compliance with GMP.
Facilitate delivery of stability samples for laboratory testing and coordinate with QC laboratories and stability supervisors to correct any discrepancies associated with stability samples for testing.
Possess experience necessary to note any uncharacteristic property of the stability samples, as the last viewer of samples before they are sent to the laboratory for testing.
Track requests for additional samples.
Generate and review monthly pull schedules for all stability testing for all active studies according to schedule timelines.
Generate work orders for preventative maintenance and repairs for all equipment associated with stability incubators to prevent product loss due to equipment failure. Ensure that the Preventative Maintenance program is executed in a timely manner.
Assure compliance of all completed test request sheets for stability, as applicable.
Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories.
Experience with entering test data into SAP.
Assist with filing of all stability records.
Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory.
Remove samples from inventory and perform required documentation for completed stability studies.
Initiate purchase orders and work orders for the Stability Group.
Performs shipment of samples between sites in a timely manner.
Train Stability staff on sample handling and inventory procedures.
Perform daily assessments of operation of the stability incubator and freezers.
Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators.
Analyzes chamber temperature and humidity trends daily to evaluate for any issues. Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant and as a preventative measure to address chamber concerns prior to any impact on studies.