Second-Shift QA Lead, Plant Quality Assurance

Replimune; Framingham (MA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Annual bonus

Equity

Health, dental, and vision insurance

401k match

Flexible PTO

Year-end holidays

Job summary

Replimune is seeking a Principal Associate I/II, Plant Quality Assurance in Framingham, MA to provide real-time quality oversight for Drug Substance, Drug Product, and related production activities in a cGMP environment.

The role reports to the Associate Director, Quality Assurance and requires collaborating with cross-functional teams across the site. This 2nd shift, Mon–Thu, 10-hour schedule is based on-site in Framingham.

Qualifications

• BA or BS in a Science or related field.
• 5-7+ years in the pharmaceutical field with 5 years in Quality or Manufacturing.
• Experience managing multiple priorities in a fast-paced environment.
• Demonstrated written and verbal communication skills, including technical writing.
• Previous Quality Assurance oversight experience.

Responsibilities

• Serve as the second shift QA lead with manufacturing teams to ensure cGMP compliance.
• Perform quality walkthroughs and inspections on the floor to maintain readiness.
• Review and approve production batch records, logbooks, and QC assays.
• Drive closure of cGMP documents and records, including deviations, CAPA, and change control.
• Author/review/approve SOPs, user requirements, risk assessments and validation docs.
• Conduct training on procedures, standard work, safety and cGMP topics.
• Internal and external audit support and continuous Quality System improvement.
• Other duties as assigned.

Skills

Quality Assurance

GMP Knowledge

Documentation

Cross-functional

Regulatory communication

Audit readiness

Education

Bachelor's degree in Science

Tools

Document control systems

CAPA management

Job description

Replimune is seeking a Principal Associate I/II, Plant Quality Assurance in Framingham, MA to provide real-time quality oversight for Drug Substance, Drug Product, and related production activities in a cGMP environment.

The role reports to the Associate Director, Quality Assurance and requires collaborating with cross-functional teams across the site. This 2nd shift, Mon–Thu, 10-hour schedule is based on-site in Framingham.