What are the responsibilities and job description for the Sterile Fill Finish Quality Expert position at Pace Life Sciences?
About Us
Pace Life Sciences advances the science of pharmaceutical and biopharmaceutical customers through the drug development process. We provide professional services to support operations, from early-phase R&D through clinical trials and GMP commercial product support.
Job Responsibilities
The ideal candidate for this role will have experience in a sterile fill finish manufacturing environment and a strong background in microbiological testing. Key responsibilities include:
- Routine and non-routine microbiological testing of raw materials, in-process samples, and finished products.
- Environmental monitoring of the manufacturing facility, including air, surface, and personnel monitoring.
- Endotoxin, bioburden, and particulate matter testing.
- Method development and validation in compliance with regulatory guidelines.
- Laboratory equipment maintenance and calibration.
- Test result documentation and review.
- Quality issue investigation and resolution.
A bachelor's or master's degree in Microbiology, Biology, or a related field is required, along with a minimum of 2-3 years of experience in a microbiology role within a sterile fill finish manufacturing environment.
