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Job: QC Specialist II, Medicago USA, DURHAM, NC
QC Specialist II
DURHAM, NC 27713 United States
Documentation & Technical Writing
Under the supervision of the QC Microbiology Supervisor, the candidate is responsible for coordination and execution of activities for quality control programs including the following responsibilities:
• Assist in the establishment and ongoing management of the QC Microbiology program.
• Perform technical writing of procedures, protocols and reports such as action excursions and quality events.
• Perform data entry and record issuance tasks supporting QC Microbiology programs.
• Perform data and document review in a timely manner
• Coordinate, 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.
• Participate in problem solving exercises to identify the potential root causes.
• Highly Innovative and be able to identify and recommend more efficient processes.
• Perform Environmental Monitoring duties to ensure that the GMP processing area is in compliance with regulatory guidelines.
• Responsible for performing microbiological testing of raw materials, In-process and utilities samples.
• Responsible for maintaining laboratory equipment in accordance with QC procedures,
• Familiar with working in a cGMP environment.
• Excellent knowledge of aseptic techniques.
• Experience with quality programs associated with biopharmaceutical laboratory operations.
• Excellent communication skills both written and oral required.
• 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, Documentation, 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 lift and or move up to 20 pounds occasionally.
• Associate degree in science with a minimum of 5 years of experience.
• Bachelor’s degree in sciences or engineering with a minimum of 4 years biopharmaceutical experience.
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North Carolina Biotechnology Center