Merakey Jobs

*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: 248 728 2629 / email: shubham.singh@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.