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Quality Assurance Deviation Investigator

3 months ago

Baltimore, United States Unicon Pharma Inc Full time

Degree in life sciences such as chemistry, biology, or closely related physical science with strong GMP background/technical writing background; Bachelor’s Degree: 7-9 years of relevant experience preferred or based on performance at Catalent, OR Master’s Degree: 2-4 years of relevant experience preferred or based on performance at Catalent. OR Doctorate Degree: 0-2 years of relevant experience preferred or based on performance at Catalent.

Strong knowledge in GMPs is required


Experience:

Ability to write Deviations for GMP environment; strong technical writing skills

Experience using TrackWise strongly preferred

Experience with of Root Cause Analysis tools is plus

Review supporting documentation including batch records, test results, CoAs, product specifications, training records, and SOPs