Job Description Insight Global is searching for a Drug Remediation Specialist to support one of our largest enterprise life sciences clients out of their manufacturing facility in Sandy, UT. This individual should be a mid-high level quality professional with specific experience with CAPA remediation and execution. You will have involvement with contamination controls, cross contamination, cleaning validation in a heavily FDA regulated environment. You will be specifically working with specifically OTC drugs and tentative final monograph antimicrobials on the production floor to ensure that quality, safety, and other regulated measures are in line with FDA regulations to ensure the production of these specific products are up to date with current standards. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.
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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements
- Bachelor's Degree in a scientific or technical field
- 7+ years of experience in a pharmaceutical/drug related quality role
- Experience evaluating and executing CAPA's
- Experience with contamination controls, cross contamination, and cleaning validation
- Drug or Pharmaceutical background HIGHLY preferred
- Technical Writing Experience
- Investigation Authorship Skills
- Master's degree or higher in a technical/scientific field
- 483 CAPA Remediation Experience