Job Summary
This role is responsible for conducting routine Environmental Monitoring (EM) sampling of personnel in controlled environments, focusing on garments, gloves, and other contact surfaces to ensure compliance with cleanliness standards.
The QC Specialist role ensures that the Red Lion Road Site EM personnel monitoring program is carried out in alignment with all site guidance documents and industry cGMP standards. They are additionally responsible for maintaining the EM workflow end to end by ensuring the timely delivery of EM personnel samples to the QC testing lab.
Responsibilities
- Execute personnel monitoring within the aseptic processing area using MODA system
- Accountable for maintaining training compliance
- Adhere to safety protocols and maintain cleanliness in all work areas, ensuring a sterile environment to prevent cross-contamination
- Maintain meticulous records of sampling activities ensuring traceability and accountability
- Collaborate with other quality control and production team members to address any issues identified during sampling
- Communicate findings and potential risks to relevant stakeholders
- Support additional site and quality functions, as needed
Skills and Experience
Essential
- Possesses strong computer skills and familiarity with quality systems
- Experience with aseptic techniques
- Understanding of microbial sampling techniques, environmental monitoring processes, and GMP regulations.
- Strong ability to meticulously conduct sampling and documenting accurately
Desirable
- Experience working in a ISO-7 cleanroom environment
- Aseptic gowning and familiar with aseptic flow/material transfer
- Experience in contributing to process improvements and efficiency gains
- Candidate –Demonstrates ability to work independently and within a team environment
- Excellent written / verbal skills / Interpersonal skills
- Ability to speak up when something is wrong
Education
Bachelor of Science in Biology, Chemistry, Engineering, or related fields
*1st, 2nd, and 3rd shifts available*