Associate Stability Research Scientist II

Job Description

Job Description

Title: Associate Stability Research Scientist II
Location: Clayton, NC
Duration: 12+ Months

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:

• 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 fulfil printing of labels for stability requests.
• Maintain and audit all sample labelling 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 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, labelling, 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.
• Analyses 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.
• 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 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.

Requirements :

• This position requires MS Degree /BS + 1-2 years/No degree + 5 years experience (for the Associate Stability Research Scientist II position). 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.

Occupational Demands:

• Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment. Exposure to chemicals.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Frequently sits and bends neck for 4-6 hours per day.
• May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats.
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs.
• May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues.
• Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence .

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\nCompany Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA