Quality Control Analyst

ClinLab Solutions Group; Hopkinton (MA); On-site; USD 65,000 - 100,000; Full time

Job summary

ClinLab Solutions Group in Hopkinton, MA is seeking a Quality Control Analyst to support environmental sampling, raw material testing, and cell therapy in-process and release testing. You will manage sample workflows, generate data reports, and contribute to SOP revisions to ensure compliant CQ quality systems.

The role emphasizes documentation, data management support, and collaboration within a fast-paced manufacturing environment focused on aseptic processing and product stability.

Qualifications

• Certificate in Biotechnology or Bachelor's degree in scientific discipline preferred.
• 2-7+ years' experience in manufacturing environment.
• Familiarity/experience in a cGMP QC laboratory is desirable.
• Ability to adhere to timelines for testing and reporting of data.
• Ability to function in a team-oriented environment.
• Experience with environmental monitoring in an Aseptic Processing facility is a plus.
• Excellent/Effective written and verbal communications skills.
• Adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Ability to work in a fast-paced, collaborative environment and manage workload based on changing priorities.

Responsibilities

• Conduct routine and non-routine analyses of samples for in-process, final product, stability, raw materials, and environmental samples.
• Execute sampling and QC Sample Management activities per procedure or written protocols.
• Perform environmental monitoring of cleanrooms and controlled areas.
• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
• Write/revise QC specific procedures and protocols for newly built Cell Therapy manufacturing facility.
• Support implementation of information technologies that support documentation and data management systems.
• May participate in investigations, change controls and CAPAs.

Skills

Organizational skills

Communication skills

Problem solving

Teamwork

Attention to detail

Education

Bachelor's degree in scientific discipline

Certificate in Biotechnology

Tools

Microsoft Office Suite

Job description

The Quality Control Analyst will be responsible for collection of environmental and raw material samples, sample management activities, and testing of cell therapy in-process, release and stability product samples. He/she will be responsible for reporting of data and writing/revising standard operating procedures (SOPs). He/she may support equipment onboarding and qualification as well as test method qualification in compliance with all applicable quality systems and current cGMPs.

How You Will Make an Impact:

• Conduct routine and non-routine analyses of samples for in-process, final product, stability, raw materials, and environmental samples.
• Execute sampling and QC Sample Management activities per procedure or written protocols.
• Perform environmental monitoring of cleanrooms and controlled areas
• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
• Write/revise QC specific procedures and protocols for newly built Cell Therapy manufacturing facility.
• Support implementation of information technologies that support documentation and data management systems.
• May participate in investigations, change controls and CAPAs.

What You Will Bring:

• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• Certificate in Biotechnology or Bachelor's degree in scientific discipline preferred
• 2-7+ years' experience in manufacturing environment
• Familiarity/experience in a cGMP QC laboratory is desirable
• Ability to adhere to timelines for testing and reporting of data
• Ability to function in a team-oriented environment
• Experience with environmental monitoring working in an Aseptic Processing manufacturing facility is a plus
• Excellent/Effective written and verbal communications skills
• Adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities