Quality Assurance Analyst

2 weeks 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 established manufacturing protocols, materials management, and laboratory practices in accordance with relevant Standard Operating Procedures (SOPs).
  • Conduct regular Good Manufacturing Practice (GMP) inspections independently and in collaboration with Quality Management teams.
  • Demonstrate excellent verbal and written communication abilities, with a strong capacity to analyze and interpret quality incident investigations.
  • Utilize knowledge of quality risk management methodologies to enhance the Quality Management System (QMS) and optimize manufacturing and testing processes.
  • Initially assess and document quality incidents (QEs) identified on the production floor.
  • Perform daily reviews of all logbook entries in both manufacturing and analytical environments.

Essential Knowledge & Skills:

  • Comprehensive understanding of FDA-regulated pharmaceutical production and testing environments.
  • Adept at identifying issues and effectively conveying them to senior management for further evaluation.
  • Proficient in managing challenges across diverse teams to ensure effective and timely resolutions.
  • Lead initiatives aimed at improving site QMS and associated processes.
  • Proactive approach with strong competencies in decision-making, problem-solving, conflict resolution, planning, organization, resource management, and training.
  • Capable of independently and efficiently handling quality-related assignments.
  • Able to implement extensive and intricate corrective and preventive measures on the production floor, with support from cross-functional teams.
  • Quickly identify conflicts or issues and alert management with suggested solutions.
  • Effectively communicate updates, challenges, projects, and necessary information verbally to diverse audiences.
  • Must maintain a "safety-first" mindset due to the proximity to radiation hazards.

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 manufacturing cleanrooms (aseptic gowning validation required), quality control laboratories, materials storage areas, and office settings.
  • Must be capable of sitting, standing, or walking for up to 50% of the workday.


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