Stefanini Group is hiring!
Stefanini is looking for Quality Lab Technician III in Marion, NC (100% Onsite work).
For quick Apply, please reach out to Shubham Singh- call: 248 ### #### / email: ...@stefanini.com
Responsibilities:
- We are seeking a skilled Quality Lab Technician with expertise in microbial investigations and validation processes to join our healthcare team.
- This role will involve performing laboratory tests, conducting microbial investigations, and supporting validation activities to ensure compliance with regulatory standards and company protocols.
- The ideal candidate will have experience in microbiology, strong attention to detail, and a thorough understanding of validation processes in the healthcare domain.
- Perform routine microbial testing and analysis on samples following established protocols and standards.
- Conduct microbial investigations to identify root causes of contamination and non-conformances.
- Document and report microbial testing results, investigations, and corrective actions.
- Support validation activities, including equipment, process, and method validation, ensuring all tests are performed in accordance with regulatory and quality standards.
- Maintain accurate records and documentation for all tests, validations, and investigations.
- Collaborate with quality assurance and regulatory teams to ensure compliance with FDA, ISO, and other applicable regulations.
- Troubleshoot and resolve lab issues and ensure all equipment is properly maintained and calibrated.
- Assist in continuous improvement initiatives for laboratory operations and quality control processes.
- Ensure laboratory practices follow Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Qualifications:
- Bachelor's degree in Microbiology, Biology, or related field.
- Minimum of 2-3 years of experience in microbial testing and investigation within the healthcare or pharmaceutical industry.
- Strong understanding of validation processes, including method, process, and equipment validation.
- Knowledge of FDA, ISO, and other relevant regulatory standards.
- Experience with GLP/GMP laboratory environments.
- Excellent problem-solving skills with a focus on detail-oriented investigation processes.
- Strong communication and documentation skills.
- Ability to work independently and collaboratively in a team environment.
Preferred Skills:
- Experience with sterility testing and environmental monitoring.
- Familiarity with laboratory information management systems (LIMS).
- Experience in validation protocol development and execution.