Sr. Associate Stability Research Scientist I

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Description

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.

Responsibilities of this position include but are not limited to:

• Maintain product inventory daily 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 Sample Specialists 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.
• 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 stability data, when applicable, for data returned from the testing laboratories.
• Experience with entering test data into the stability databases, Stability System and/or 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.
• Trains 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 Stability chamber temperature and humidity trends daily to evaluate for any issues. Performs weekly, monthly, and annual reviews to ensure all equipment remains compliant, and as a preventative measure to address chamber concerns prior to any impact on studies.

In addition to the above requirements, the M06 position will have the following requirements:

• Primary contact for addressing chamber alarms (24/7). Responsible for implementation of a plan of action and notification of management. Leads inter-departmental effort to quickly address issues so that stability studies are not impacted. This includes getting approval of other functional area personnel and potential off-shift relocation of stability samples in a manner to ensure that the quality of the product is maintained for stability purposes. Organizes moves for samples as required.
• Assists supervisor with planning schedule for weekly activities.
• Assists supervisor with performing weekly audits of stability areas, assessing for both GMP and Safety items. Provides report to management and follows up on any corrective actions.
• Participates in investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory.
• Conduct weekly audits of logbooks and temperature charts for all stability incubators.
• Assists with information needed for chamber activities.
• Primary contact for interactions with Instrumentation and Validation for calibration and validation of stability equipment.
• Issues logbooks for Stability Equipment.
• Authors the monthly report on chamber activities to show what was accomplished, and tracks and trends activities to determine load and necessary resources.

Requirements

This position requires a MS Degree + 1 year experience, a BS degree + 3-4 years experience, or no degree + 7 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.

An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required. Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical. The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of the organization, supporting departmental objectives and management decisions, and maintaining good working relations with multiple cross-functional teams. The incumbent must possess a working knowledge of equipment and storage facility operations and be able to quickly resolve problems associated with chamber related issues. The incumbent must possess excellent skills regarding determination of the impact of a deviation upon the stability program and be able to ensure corrective actions for each discrepancy have been implemented and are effective to prevent reoccurrence. The incumbent must possess computer skills regarding working use of word-processing, spreadsheet, and e-mail programs. Training and working knowledge on the following are required for consideration for this position: ScienTek Stability System program, Loftware labeling solutions software and Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System and TempTale Monitoring Devices. Prior experience with visual inspection and vial integrity testing is necessary, as is experience with shipment of biological samples. This position requires the ability to perform basic calculations in addition to the need for keen assessment skills and extreme attention to detail. The incumbent must possess effective verbal and written communication skills. The incumbent must have experience with creating or revising SOPs. The incumbent must keep neat, accurate, complete, and timely records. They must demonstrate initiative and willingness to learn. The incumbent must be able to carry out tasks independently or with minimal supervision and be able to function in a team environment. The responsibilities of this position directly affect the quality of marketed and developmental products stored in the Stability program, which are valued in the millions of dollars.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

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