Gene Therapy QC Specialist — Hybrid (2–3 Onsite Days)

Actalent; Boston (MA); Hybrid; USD 69,000 - 79,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

HSA

Job summary

Actalent is seeking an experienced QC Specialist to support quality control across gene therapy programs. You will oversee external testing partners, manage QC and stability data, and ensure GMP compliance while supporting analytical methods lifecycle activities.

The role requires strong QC experience in life sciences, CMOs/CROs oversight, stability programs, and data analytics. Hybrid work, with 2–3 days onsite weekly in Charlestown, MA, is offered along with comprehensive benefits.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, or Life Science.
• 5+ years in Quality Control within a regulated life sciences environment.
• 3+ years overseeing external partners (CMOs/CROs).
• Experience with analytical method transfers, qualifications, and validations.
• Strong GMP knowledge and stability study experience.
• Hands-on investigations, deviations, change controls, OOS/OOT.

Responsibilities

• Manage and review QC data from external contract manufacturers and testing organizations.
• Review release and stability data for accuracy, completeness, and regulatory compliance.
• Analyze and trend QC data using JMP and GraphPad.
• Support stability programs, including sample tracking, data review, and reporting.
• Draft and maintain QC docs: SOPs, specs, protocols, reports, COAs.
• Collaborate on method qualification, validation, transfer, and fit-for-purpose assessments.
• Support reference standard management and related documentation.
• Initiate/deal with deviations, OOS/OOT investigations, impact assessments, change controls.
• Provide technical oversight of external partners to ensure quality and compliance.
• Use eQMS tools (Veeva/MasterControl/ZenQMS).
• Cross-functional collaboration to support programs and continuous improvement.

Skills

Quality control

GMP compliance

Data trending

CRO/CMO oversight

Documentation

Education

Bachelor's degree in Life Sciences

Tools

JMP

GraphPad

Veeva/MasterControl/ZenQMS

Job description

Actalent is seeking an experienced QC Specialist to support quality control across gene therapy programs. You will oversee external testing partners, manage QC and stability data, and ensure GMP compliance while supporting analytical methods lifecycle activities.

The role requires strong QC experience in life sciences, CMOs/CROs oversight, stability programs, and data analytics. Hybrid work, with 2–3 days onsite weekly in Charlestown, MA, is offered along with comprehensive benefits.