QC Analytical Scientist I – GMP Lab & Compliance

Replimune-2; Framingham (MA); On-site; USD 112,500 - 146,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune Group, Inc. in Framingham, MA, is seeking a Scientist I/II, QC Analytical to perform QC testing per SOPs and cGMP. This role may oversee junior staff and support QC lab systems, scheduling and review of tests for materials, in-process, drug substance and final product.

The position requires maintaining GMP compliance in the QC lab, with on-site work five days a week at our Framingham location. Strong analytical experience and teamwork are essential.

Qualifications

• 5+ years of experience working in GMP/GLP environment or similar set up.

Responsibilities

• Establish, revise and maintain procedures for QC Analytical testing.
• Maintain QC systems related to raw materials, in-process, drug substance and final drug product sample testing.
• Review testing data of other analysts.
• Assist with the maintenance of QC laboratory and equipment.
• Responsible for the protocol and report generation of method qualifications related to QC tests.
• Perform QC Analytical testing of raw materials, in-process, water and product samples following SOPs.
• Review and complete documentation in accordance with cGMP.
• Change control, deviations and CAPAs related to QC Analytical operations including OOS/OOT investigations.
• Assist with audits and regulatory inspections, as needed.
• QC lab equipment validation.
• Interact with internal and external groups to communicate QC requirements.
• Oversee sampling and storage of QC samples and retention inventory.
• Coordinate shipping of samples to contract testing laboratories.
• Train others within department.
• Understanding of USP/EP monograph testing requirements.

Skills

GMP/GLP experience

Analytical techniques

MS Word

Excel

Communication

Teamwork

Organizational skills

Education

BA/BS in analytical chemistry

Tools

MS Word

Excel

Job description

Replimune Group, Inc. in Framingham, MA, is seeking a Scientist I/II, QC Analytical to perform QC testing per SOPs and cGMP. This role may oversee junior staff and support QC lab systems, scheduling and review of tests for materials, in-process, drug substance and final product.

The position requires maintaining GMP compliance in the QC lab, with on-site work five days a week at our Framingham location. Strong analytical experience and teamwork are essential.