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Associate Stability Research Scientist II

inSync Staffing

  • Clayton, NC
  • 5 days ago
  • $29–$30 Per Hour
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Skills

  • Biotech and Pharmaceuticalunmatched
  • Data Entryunmatched
  • DeltaVunmatched
  • Dental Insuranceunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • High School Diplomaunmatched
  • IBM Maximo Asset Managementunmatched
  • ICH Regulationsunmatched
  • Inventory Managementunmatched
  • Laboratory Testingunmatched
  • Maintain Complianceunmatched
  • Maintenance Servicesunmatched
  • Mathematicsunmatched
  • Plasmaunmatched
  • Presentation/Verbal Skillsunmatched
  • Preventative Maintenanceunmatched
  • Printersunmatched
  • Printingunmatched
  • Product Programsunmatched
  • Product Safetyunmatched
  • Quality Controlunmatched
  • Regulatory Complianceunmatched
  • Research & Development (R&D)unmatched
  • SAPunmatched
  • Scientific Researchunmatched
  • Stability Analysisunmatched
  • Staff Trainingunmatched
  • Technical Supportunmatched
  • Test Dataunmatched
  • Test Labunmatched
  • Testingunmatched
  • Trend Analysisunmatched
  • Writing Skillsunmatched

Description

Job Title: Associate Stability Research Scientist II
Location: Clayton, NC 27520
Pay Rate: $29.00 - $30.00 / Hour
Work Schedule: Monday - Friday, 7:30 AM - 4:00 PM
Job Overview:
The Associate Stability Research Scientist II provides scientific and technical support in the research and development of plasma derived or recombinant proteins. This position supports the Stability Group by overseeing all facets of the stability program related to stability chamber areas, sample inventory storage, delivery, and documentation. The role ensures a compliant stability program for licensed products and developmental projects to maintain on-going product safety and quality.
Job Specifications:
  • Maintain product inventory for active stability studies in accordance with compliance requirements, ensuring accountability, delivery of samples, and issuance of testing documentation.
  • Coordinate with Packaging to acquire batch samples for placement into the stability program.
  • Maintain label printers to ensure continuous printing capability for stability requests.
  • Maintain and audit sample labeling and documentation for accuracy and GMP compliance.
  • Facilitate delivery of stability samples for laboratory testing and coordinate with QC Sample Specialists and stability supervisors to resolve discrepancies.
  • Perform initial visual checks to note any uncharacteristic properties of stability samples before shipment to testing laboratories.
  • Generate and review monthly pull schedules for active stability studies and track requests for additional samples.
  • Generate work orders for preventative maintenance and repairs for stability incubators to prevent product loss; ensure execution of the Preventative Maintenance program.
  • Conduct check-in procedures for receipt of test data from laboratories and enter data into stability databases (ScienTek, SAP).
  • Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, or sample inventory.
  • Remove samples from inventory and perform required documentation for completed stability studies.
  • Perform daily assessments of stability incubators and freezers, including daily trend analysis of chamber temperature and humidity; conduct investigations for temperature excursions.
  • Perform weekly, monthly, and annual equipment reviews to ensure continuous compliance and preventative management.
  • Handle sample shipments between sites and train stability staff on sample handling and inventory procedures.
Qualifications and Experience:
  • Relevant experience in a regulated pharmaceutical industry stability program.
  • Understanding of ICH guidelines and GMP requirements regarding stability product storage.
  • Working knowledge of stability equipment and storage facility operations, with the ability to resolve chamber-related issues and assess deviation impacts.
  • Required experience with visual inspection, vial integrity testing, and shipment of biological samples.
  • Required technical proficiency in: ScienTek Stability System program, Loftware labeling software, Intermec printers, SAP, DeltaV Monitoring System, LabWatch, Maximo Management System, and TempTale Monitoring Devices.
  • Strong written and verbal communication, mathematical calculation skills, and high attention to detail.
Education Requirements:
  • Master s Degree; OR Bachelor s Degree with 1 2 years of relevant experience; OR High School Diploma/No Degree with 5+ years of relevant experience. (Degree emphasis in a scientific field preferred).
Benefits (employee contribution):
  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

Numbers & Facts

LocationClayton, NC
IndustryStaffing/Employment Agencies
Salary$29–$30 Per Hour
Company Size50 to 99 employees
Year Founded2014
Websitehttp://www.insyncstaffing.com/default.html

About Company

We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible. inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced. The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.

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