Second‑Shift Principal QA Associate, Plant

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Paid Time Off

Job summary

Replimune in Framingham, MA, seeks a Principal Associate I/II, Plant Quality Assurance for a second-shift role providing real-time quality oversight across Drug Substance, Drug Product, and QC testing to maintain cGMP and GDP compliance. This position requires collaboration across departments and on-site presence in Framingham.

The ideal candidate has 5–7+ years in pharma QA/manufacturing, with strong communication and documentation skills, and a BA/BS in science.

Qualifications

• 5–7+ years of experience in the pharmaceutical field with QA or manufacturing roles.
• Experience managing multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills, including technical writing.

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.
• Close out cGMP documents (deviations, CAPA, change controls) and validation docs.
• Author/review/approve SOPs, risk assessments, training materials and engineering docs.
• Train staff on procedures, standard work, safety and cGMP topics.

Skills

Quality Oversight

cGMP Compliance

Documentation & Records

Cross-functional Collaboration

Quality Assurance

Education

BA/BS in Science

Tools

LIMS

MS Office

Job description

Replimune in Framingham, MA, seeks a Principal Associate I/II, Plant Quality Assurance for a second-shift role providing real-time quality oversight across Drug Substance, Drug Product, and QC testing to maintain cGMP and GDP compliance. This position requires collaboration across departments and on-site presence in Framingham.

The ideal candidate has 5–7+ years in pharma QA/manufacturing, with strong communication and documentation skills, and a BA/BS in science.