Quality Assurance (QA) Roles (Entry To Mid-Level) (Day-Shift) (Biologics)

TL;DR

Quality Assurance Specialist (Biologics): Ensuring compliance of products, processes, and systems within Cell Therapy and Biologics operations with an accent on GMP standards, deviation management, and batch record review. Focus on executing root cause analysis, implementing CAPAs, and maintaining regulatory compliance in a highly regulated manufacturing environment.

Location: Onsite in Portsmouth, NH, USA

Company

Global leader in the life sciences sector, managing over 30 sites across five continents to manufacture advanced medicines.

What you will do

• Ensure full compliance with GMP, regulatory requirements, and internal quality standards.
• Review and approve batch records, protocols, reports, and other quality documentation.
• Lead or support deviation investigations, root cause analysis, and CAPA implementation.
• Provide on-the-floor quality assurance support to manufacturing and operations teams.
• Participate in internal, client, and regulatory audits and inspections.
• Collaborate cross-functionally with Manufacturing, QC, Regulatory, and Engineering teams.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Must be based in or able to work onsite in Portsmouth, NH.
• Basic understanding of GMP or experience working in regulated environments.
• Strong attention to detail and ability to accurately follow SOPs.
• For mid-level roles: 3–7+ years of QA experience within a GMP-regulated industry.

Nice to have

• Hands-on experience with quality systems such as TrackWise, Veeva, or LIMS.
• Proven experience with batch record review and managing complex quality investigations.
• Previous experience supporting regulatory inspections.

Culture & Benefits

• Opportunity for career growth across multiple QA functions and levels.
• Collaborative environment driven by values of accountability, excellence, and integrity.
• Work within a globally connected team supporting breakthrough therapies.
• Commitment to diversity, equity, and equal employment opportunities for all applicants.