QC Analyst (Microbiology)

Role Summary

QC Analyst (Microbiology) in Framingham, MA. The Quality Control team develops and validates methodologies using state-of-the-art technology and ensures that production lots and materials meet quality standards, supporting regulatory compliance and operational excellence. Shift: Wednesday–Saturday, 7:00 a.m.–5:30 p.m.

Responsibilities

• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks
• Recording all expected raw data, calculations, information related to tasks, to comply with cGMP and data integrity requirements
• Ensuring that the analyst is trained and qualified for the assigned analytical testing
• Performing the QC data review of executed tests by other analysts in a timely manner
• Informing the manager of any quality or HSE event (deviations, OOS) in a timely manner to ensure investigations and impact assessments are performed appropriately
• Participating actively in investigations where involved to ensure investigations and impact assessments are performed appropriately
• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that lab facilities and instruments are kept in a quality and safety status to ensure that they can be used appropriately

Qualifications

• Required: High School Diploma with minimum of 4 years of relevant industry experience
• Required: Associates Degree with 2-4 years of relevant industry experience
• Required: Bachelor's Degree with 0-2 years of relevant industry experience
• Required: Proficient with Microsoft Office tools such as Word, Excel & PowerPoint
• Preferred: 1 Year of Experience in a GMP lab environment
• Preferred: Experience with lab-based data management systems
• Preferred: Experience in a Quality Control Laboratory
• Preferred: Experience with Environmental Monitoring, including Water Testing

Additional Requirements

• Ability to perform tasks in a Quality Control Laboratory environment and capable of lifting at least 10 pounds
• May be required to pass vision exam to perform specific responsibilities
• May be required to enter into controlled environments following proper gowning protocols