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Senior Quality Specialist

2 months ago

Wilson, United States Cynet Systems Inc. Full time

Education and Experience:

  • Requires a Bachelor’s degree, preferably in a scientific discipline, with a minimum of 6 years of experience in a pharmaceutical or related industry or a graduate degree (MS preferred) with two years of experience in a pharmaceutical or related industry.
  • Demonstrated sound understanding, well-developed working knowledge, and ability in primary discipline.

Knowledge, Skills, and Abilities:

  • Investigation into any unexplained discrepancies must be evaluated in terms of cGMPs, FDA requirements, NDA commitments, and impact on product quality, safety, and efficacy.
  • The incumbent must be able to drive deviations to determine the true root cause and identify appropriate CAPAs to prevent a recurrence.
  • Help the Quality team to meet day-to-day assignments.
  • Demonstrate excellent understanding of cGMP’s, FDA regulations, and pharmaceutical manufacturing processes.
  • Identifies and resolves in-depth issues through collaboration with others.
  • Partners with colleagues in identifying and resolving potential compliance concerns.
  • Interfaces with appropriate Warehousing, Planning, Pharmacy, Operations, and Quality Management to implement the procedural requirements as outlined and within internal operating procedures.
  • Identifies and proposes opportunities for continuous improvement of quality systems.
  • Effectively performs root cause analyses and determines corresponding corrective measures.
  • Working knowledge of Track Wise and Veeva is a plus.