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Job (this posting is now closed/inactive)

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General Information


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Job location: Durham, NC  27713 United States
Requisition code:
Date posted: 01/02/2018
Job category:Quality Control
Employment type:Full time
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Job Description

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Under the supervision of the QC Biochemistry Supervisor, the candidate is responsible for the coordination and execution of activities for quality control programs including the following responsibilities:

QC Systems
• Assist in the establishment and ongoing management of QC programs
• Perform data entry and record issuance tasks supporting QC programs
• Perform data and document review
• Responsible for performing Biochemistry and analytical testing (i.e. ELISA, UPLC, SDS-PAGE)
• Responsible for maintaining laboratory equipment in accordance with QC procedures
• Assist with technical writing of procedures, protocols and reports
• Organize, assemble, and route documentation to support QC document review and approval as required by Quality Systems Management
• Prepare and provide timely and accurate reports and assessments of assigned project(s) and quality metrics to the QC Management
• Participates in problem solving exercises to identify the potential root causes
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Job Requirements

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• Familiar with working in a cGMP environment
• Experience with quality programs associated with biopharmaceutical laboratory operations
• Excellent communication skills both written and oral required
• Experience with Waters HPLC/UPLC and Empower software preferred
• Must be well organized and have the ability to multitask in a fast paced environment
• Attention to detail and good documentation practices
• Self-starter, results-oriented individual with ability to organize and analyze data
• Proficiency with MS Office applications required
• Experience with enterprise applications (example: LIMS, Trackwise, Documentum, SAP) preferred
• The employee is required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl
• The employee must occasionally lift and/or move up to 20 pounds


• A Bachelor’s degree in science or engineering is preferred with 2 - 4 years of experience.
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