Job Description: We are seeking a skilled and detail-oriented Microbiologist to join our Quality Control team. The ideal candidate will have experience in a sterile fill finish manufacturing environment and a strong background in microbiological testing. This role is essential to ensuring the sterility and safety of our products.
Key Responsibilities:
- Perform routine and non-routine microbiological testing of raw materials, in-process samples, and finished products.
- Conduct environmental monitoring of the manufacturing facility, including air, surface, and personnel monitoring.
- Perform endotoxin, bioburden and particulate matter testing.
- Develop and validate microbiological methods in compliance with regulatory guidelines.
- Maintain and calibrate laboratory equipment and instruments.
- Document and review test results accurately and promptly.
- Investigate and resolve any microbiological quality issues or deviations.
- Collaborate with cross-functional teams to support product development and manufacturing processes.
- Ensure compliance with GMP, GLP, and other regulatory requirements.
Qualifications:
- Bachelor's or Master's degree in Microbiology, Biology, or a related field.
- Minimum of 2-3 years of experience in a microbiology role within a sterile fill finish manufacturing environment.
- Proficiency in microbiological techniques such as aseptic techniques, microbial enumeration, and endotoxin testing.
- Strong understanding of GMP, GLP, and regulatory requirements.
- Excellent attention to detail and problem-solving skills.
- Ability to work independently and as part of a team.
- Strong communication and documentation skills.
Pace® Life Sciences
Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.