Quality Control Analyst I - Lab GMP & Data Review

Replimune; Woburn, Northern (MA, KY); Hybrid; USD 34,000 - 56,000; Full time

Job summary

Replimune in Milton Park seeks a QC Laboratory Technician to perform routine QC testing and manage sample inventories. You will follow SOPs, maintain cell lines, and support data review for reports while contributing to cGMP/compliance.

Based on site expectations, this role is primarily on-site with strong attention to accuracy, collaboration, and documentation. A chemistry/biochemistry degree and meticulous lab skills are essential for success.

Qualifications

• Degree in Chemistry/Biochemistry/ other related science
• Competent analytical skills and attention for details
• Understanding of GMP requirements preferred
• Computer literacy
• Ability to work independently and with others in a team.

Responsibilities

• Perform QC testing of various samples according to Standard Operating Procedures (SOPs).
• Maintain various cell lines on regular basis by revival and passaging at set intervals.
• Review testing data and records of other operators and data verification for reports.
• Perform QC sample and material receipt and maintain inventory.
• Routine equipment maintenance as required.
• Write or revise SOPs, protocols, FORMs and update as required.
• Participate in QC method transfers, qualification, 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 QC documents and assist with investigations and other documentation as required.
• Assist with internal and regulatory agency audits / inspections.

Skills

Analytical skills

Attention to detail

GMP knowledge

Computer literacy

Teamwork

Education

Degree in Chemistry/Biochemistry/ other related science

Job description

Replimune in Milton Park seeks a QC Laboratory Technician to perform routine QC testing and manage sample inventories. You will follow SOPs, maintain cell lines, and support data review for reports while contributing to cGMP/compliance.

Based on site expectations, this role is primarily on-site with strong attention to accuracy, collaboration, and documentation. A chemistry/biochemistry degree and meticulous lab skills are essential for success.