Location: Sanford, North Carolina
Posted On: 8/12/2017
Job Code: 8353-1
Job Description
• The position will support the Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product; critical reagents, controls, standards, raw materials; validation; and stability. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control laboratories; o Prepare, manage (1person), and implement critical reagents, standards, and controls o Testing; analyzing, interpreting, and trending results o Creating, reviewing and approving documentation (e.g. procedures, protocols, and reports). • Performs tasks associated with maintaining GMP compliant Quality Control and Stability laboratories with a specific focus on standards/controls/critical reagents preparation, program management (1 person), implementation. • Performs testing including, but not limited to clinical and/or commercial standards/controls/critical reagents, product, raw materials and validation samples. • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance. • Responsible for appropriate creation, review, associated data trending, and approval of GMP documentation (test records, protocols/reports, test methods, equipment records, etc.) • Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS result and participating in associated laboratory investigation, reporting instrument issues and assisting with troubleshooting, etc.) • Laboratory Information Management System (LIMS), MS Office™ applications specifically Word and Excel • Good written and verbal communication techniques • Ability to follow written procedures and learn from hands on training • Capability of solving complex mathematical and situation dependent problems • Analytical Chemistry and/or Microbiology techniques and instrumentation,
Category:Non-IT  code:new
Job Requirements
MS Word, Information Management, Training, MS Office, Compliance, Focus, Chemistry, MS Excel, Program Management, Management, Quality Control

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Contact Details
Shubham B
E-mail Address