The Role
- You will ensure that the Environmental Monitoring samples are collected and tested for aseptic facilities, such as surface, water, and air sampling.
- You will review Environmental monitoring samples according to quality requirements and ensure results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.
- Document test results in appropriate records and computer systems.
- Support documentation and records, distributing, and filing all manufacturing procedures, and deviations.
- Follow Standard Operating Procedures (SOPs) and maintain compliance with current Good Manufacturing Practice (cGMP) regulatory guidelines.
- This role requires up to 10 hours of standing, some light inventory/stocking work, and gowning into Zone B, C, and D areas.
- Must be able to adjust to schedule changes, be able to problem solve, have critical thinking skills, and be equally able to work with a team and independently.
Minimum Required Qualifications:
- Associate's Degree or Biowork Certificate
- Min 1-year experience in Pharma
- GDP experience
- Experience with Environmental Monitoring, Water collection, aseptic gowning and technique, and plate reading
- This role requires up to 10 hours of standing, some light inventory/stocking work, and gowning into Zone B, C, and D areas.
- Must be able to adjust to schedule changes, be able to problem solve, have critical thinking skills, and be equally able to work with a team and independently.
Preferred / Nice to Have Qualifications:
- LIMS experience is a plus
- MetOne particle counter
- SAS air sampler
