***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.