Clinical Operations

  • location: Rocky Mount, NC
  • type: Contract
  • salary: $33.66 - $39.60 per hour

job description

Clinical Operations

Job Title: CQ Investigator III

Job Summary

  • 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 of the organization.
Job Responsibilities

  • 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
Education & Qualifications

  • BS degree in science field is required and advanced degree (MS or Ph D degree) preferred
  • 5 or more years' experience in a Chemistry Laboratory.
  • Operational and Technical knowledge of Analytical Techniques. (i.e. HPLC, GC, AA, FTIR, UV-VIS, ICP-MS, wet chemistry).
  • 2 or more years experience conducting OOS/OOT/OOL Laboratory investigations.
  • Strong critical thinking and problem solving skills.
  • 4 or more years in a pharmaceutical facility.
  • 4 years' experience in a manufacturing site is preferred.
  • Minimum 2 years leadership experience preferred
  • Excellent verbal and written communication skills and attention to detail.
  • Experience in Trackwise system preferred
  • Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.
  • Ability to work cross-functionally with a diverse team.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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