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QA Compliance Specialist

2 months ago

Elizabeth, New Jersey, United States Astrix Full time

Salary: 60,000/yr

Location: Union City, NJ

Employment Type: Direct Hire

Key Responsibilities:

  • Ensure adherence to manufacturing standards, materials management, and laboratory operations in line with established SOPs.
  • Conduct regular GMP inspections both independently and in collaboration with Quality Management.
  • Demonstrate excellent verbal and written communication abilities, along with the capacity to analyze and interpret quality incident investigations.
  • Utilize quality risk management techniques to enhance the Quality Management System (QMS) and optimize manufacturing and testing processes.
  • Initially assess and manage quality incidents occurring on the production floor.
  • Review logbook entries in both manufacturing and analytical environments on a daily basis.

Required Knowledge & Skills:

  • Comprehensive understanding of FDA-regulated pharmaceutical production and testing processes.
  • Adept at identifying issues and effectively conveying them to upper management for further evaluation.
  • Ability to coordinate resolutions across diverse teams to ensure effective outcomes.
  • Lead initiatives aimed at improving site QMS and associated activities.
  • Proactive approach with strong capabilities in decision-making, problem-solving, conflict resolution, planning, organization, resource management, and training.
  • Capable of independently managing quality-related responsibilities efficiently.
  • Able to execute extensive corrective and preventive actions on the production floor, supported by cross-functional teams.
  • Quickly identify conflicts or issues and inform management with suggested solutions.
  • Effectively relay updates, challenges, projects, and necessary information verbally to all stakeholders.
  • Must maintain a "safety-first" mindset due to the nature of the work environment.

Basic Qualifications:

  • Bachelor's degree in a STEM discipline; equivalent combinations of education and experience may be considered.
  • Minimum of 2 years of experience in a GMP setting.
  • Familiarity with pharmaceutical production and laboratory operations.
  • Role involves time spent in controlled manufacturing environments, quality control laboratories, materials storage areas, and office settings.
  • Must be able to sit, stand, or walk for up to 50% of the workday.