Associate Stability Research Scientist

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve. Associate Stability Research Scientist IIM-F, 8am – 4:30pmFrom Manager:The incumbent will provide technical and scientific expertise in the research and development of plasma derived proteins utilizing separations based analytical techniques such as HPLC, Capillary Electrophoresis and SDS-PAGE. Working knowledge of Waters Empower is essential and a proficiency in Chromelen is highly desirable. Must have experience developing and qualifying methods based on ICH guidelines.This is the official 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 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 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 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.Understanding of ICH guidelines and GMP requirements related to the storage of Stability productsStrong written and verbal communication skills to produce clear, accurate, and logical reportsExcellent interpersonal skills to interact effectively with all organizational levels and cross-functional teamsWorking knowledge of equipment and storage facility operations, with the ability to quickly resolve chamber-related issuesAbility to assess the impact of deviations on the stability program and ensure effective corrective and preventive actions (CAPA)Proficiency with computer applications, including word processing, spreadsheets, and emailRequired training and working knowledge of:ScienTek Stability SystemLoftware labeling software and Intermec printersSAPDeltaV Monitoring SystemLabWatchMaximo Management SystemTempTale Monitoring DevicesPrior experience with visual inspection, vial integrity testing, and shipment of biological samplesAbility to perform basic calculations with strong analytical skills and extreme attention to detailDemonstrated ability to maintain neat, accurate, complete, and timely recordsInitiative and willingness to learn new processes and systemsAbility to work independently with minimal supervision as well as collaboratively in a team environmentAwareness that responsibilities directly impact the quality of high-value marketed and developmental products within the Stability programRequirements: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 performed in a clinical and/or laboratory environmentPotential exposure to biological fluids, infectious organisms, chemicals, and electrical office equipmentPersonal protective equipment (PPE) required, including protective eyewear, garments, and glovesPhysical Demands:Frequently sits and bends neck for 4–6 hours per dayMay stand and twist neck for 2–4 hours per dayOccasionally walks, bends, twists at the waist, and squatsFrequent bilateral hand use with fast, simple finger, hand, and wrist movementsAbility to make precise, coordinated finger movements to grasp and manipulate objectsModerate lifting of 15–30 lbs, with a maximum lift of 35 lbsAbility to reach above and below shoulder heightVision & Communication:Color perception and discrimination requiredNear and far vision required (correctable to 20/30 in one eye and 20/100 in the other)Ability to communicate complex information clearly and effectivelyStrong listening skills to understand spoken information and ideasCognitive & Work Requirements:Frequently works with diverse groups to reach consensus on complex issuesAbility to apply abstract principles to solve complex conceptual problemsPerforms a wide range of complex tasks in a dynamic environment with variable demands and limited predictabilityCompany DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Salary : $38 - $41