Senior QC Analyst - GMP Lab Lead, On-Site

Replimune; Woburn, Northern (MA, KY); Hybrid; USD 55,000 - 70,000; Full time

Job summary

Replimune seeks a QC Technician to perform routine and non-routine QC testing following SOPs, reagent prep, tissue culture, and equipment maintenance at our on-site facility. You will manage samples, inventories, write and update documents, and support audits. Strong GMP/GDP awareness and team collaboration are essential.

Based in Milton Park on-site, the role involves hands-on lab work, data accuracy, and contributing to validation activities and method transfers.

Qualifications

• 3+ years of laboratory-based experience in similar environments.
• Competent analytical skills and attention to detail.
• Understanding of GMP requirements.
• Computer literacy (MS Word/Excel); good communication and organizational skills.
• Ability to work independently and with others in a team.

Responsibilities

• Perform QC testing of routine and non-routine samples according to SOPs.
• Maintain various cell lines on a regular basis by revival and passaging at set intervals.
• Perform QC sample and material receipt and maintain inventory.
• Routine equipment maintenance and troubleshooting as required.
• Lead introduction of new equipment and participate in validation activities.
• Write, update or review SOPs, protocols, FORMs and update as required.
• Participate in QC method transfers, validation, and stability activities.
• Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).
• General lab tasks such as housekeeping, inventory of supplies, order supplies etc.
• Write deviations/CAPA/Change controls related to QC and assist with investigations related to OOS and OOT results.
• Become a trainer in method as processes and train junior member of the team as required.
• Assist with internal and regulatory agency audits / inspections.
• Ensure training is kept in GMP compliant state.

Skills

Laboratory experience

GMP knowledge

Data integrity

Attention to detail

MS Word/Excel

Education

Degree in Chemistry/Biochemistry or related science

Tools

-

Job description

Replimune seeks a QC Technician to perform routine and non-routine QC testing following SOPs, reagent prep, tissue culture, and equipment maintenance at our on-site facility. You will manage samples, inventories, write and update documents, and support audits. Strong GMP/GDP awareness and team collaboration are essential.

Based in Milton Park on-site, the role involves hands-on lab work, data accuracy, and contributing to validation activities and method transfers.