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CQ Investigator I
Ref No.: 18-01256
Location: Rocky Mount, North Carolina
Start Date / End Date: 06/01/2018 to 11/30/2019
The CQ Investigator is responsible for completing Laboratory investigations, providing documented evidence of root cause and Corrective and Preventative Actions for plant quality issues. This individual will work closely with employees at multiple levels within the organization in order to achieve timely completion of investigations. The role requires interactions with colleagues within the Rocky Mount site as well as external colleagues within and outside Pharmaceutical organization.

JOB RESPONSIBILITY
• Conduct and write formal investigation reports with the assistance of plant personnel and oversight from manager.
• Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
• Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
• Spearhead implementation of improvements to analytical test methods through change control process

QUALIFICATION:
• Minimum of 5 years’ experience in a science related position, pharmaceutical industry preferred.
• 4 years’ experience in a manufacturing site.
• 4 or more years in a pharmaceutical facility.
• Minimum 2 years leadership experience preferred
• BS degree in science field is required and advanced degree (MS or Ph D degree) preferred
• Excellent verbal and written communication skills and attention to detail.
• Experience in laboratory technical skills are required (i.e. chromatographic techniques, HPLC, GC, UPLC; wet chemistry techniques, AA, FTIR, UV-VIS ).
• Experience in Trackwise system preferred
• Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.
• Demonstrated ability to write logically and consistently.
• Strong critical thinking and problem solving skills.
• Resourceful and innovative approach.
• Ability to work cross-functionally with a diverse team.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives