Quality Assurance Specialist

3 weeks ago


Chapel Hill, United States Astrix Full time

***NO RELOCATION ASSISTANCE OR SPONSORSHIP AVAILBLE***


We are seeking a Quality Control Specialist with Environmental Monitoring experience to join our driven research team. This is an amazing opportunity to work with a team that develops and supports an array of outstanding health sciences research programs. As a team you will have the opportunity to foster programs in the areas of basic, translational, mechanistic, and population research


Pay: 75K


Schedule: M-F 8:30am-5pm


Location: Chapel Hill, NC


Responsibilities

  • Conduct testing, review results, and analyze the trending of data.
  • Assist in investigations and deviations and completion of Corrective and Preventative Actions (CAPAs).
  • Support EM program and ensure protocols are followed
  • Track and trend environmental monitoring, investigate environmental occurrences, and assist in review of contamination events.
  • Execute EM Testing in support of manufacturing processes
  • Work with third party vendors to assist in the development of an Environmental Monitoring program.
  • Creation of a baseline study to understand the environment of the facility.
  • Work with QC Specialist - Equipment to ensure cleanrooms are qualified within the required timeframe.
  • Schedule EM monitoring of rooms for static and dynamic testing and ensure adherence to schedule.
  • Train staff and assess competencies on appropriate aseptic techniques and gowning process.
  • Assist in the creation, modification and revisions of Policies, Standard Operating Procedures, forms, worksheets, and job aids as applicable.


Education And Experience Required

  • Bachelors of science degree is required.
  • 3+ years of GMP environmental monitoring experience.
  • 3+ years of environmental monitoring within cellular therapy is preferred.


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