QC Analyst

Role Summary

QC Analyst (Microbiology) located in Framingham, MA. Shift options: Sun-Wed 12:00 pm - 10:30 pm or Wed-Sat 12:00 pm - 10:30 pm. The role involves executing analytical testing, ensuring compliance with cGMP and HSE, and supporting quality control investigations and continuous improvement within a GMP environment.

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 associated instructions, procedures, and records
• Recording all expected raw data, calculations, and information related to tasks to comply with cGMP and data integrity requirements
• Ensuring training and qualification for assigned analytical testing
• Performing QC data review of executed tests in a timely manner, ensuring adherence to schedules
• Informing management of any quality or HSE events (deviations, OOS) to ensure proper investigations and impact assessment
• Participating in investigations where involved to ensure proper investigations and impact assessment
• Executing assigned CAPAs related to remediation plans and continuous improvements
• Maintaining lab facilities and instruments in quality and safety status for proper use

Qualifications

• Required: High School Diploma with a minimum of 4 years of relevant industry experience
• Required: Associate Degree with 2-4 years of relevant industry experience
• Required: Bachelor‚Äôs Degree with 0-2 years of relevant industry experience
• Required: Proficient with Microsoft Office tools (Word, Excel, PowerPoint)
• Preferred: 1 year of experience in a GMP lab environment
• Preferred: Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)
• Preferred: Experience with lab-based data management systems
• Preferred: Experience in a Quality Control Laboratory
• Preferred: Experience with Environmental Monitoring, including Water Testing

Skills

• Analytical testing and data integrity
• cGMP and HSE compliance
• Laboratory instrumentation and data review
• CAPA implementation and root cause analysis
• Strong documentation and record-keeping

Education

• High School Diploma; or Associate Degree; or Bachelor‚Äôs Degree as stated under Qualifications

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