Onsite QA Specialist – ISO/GMP, CAPA & Audits

ACTalent; Waltham (MA); On-site; USD 48,000 - 54,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Transportation benefits

PTO / Vacation or Sick Leave

Job summary

Actalent is seeking a Quality Assurance Specialist for a contract role onsite in Waltham, MA. You will manage QA documentation, support regulatory compliance, and assist with audits to ensure readiness and successful outcomes.

You will collaborate with cross-functional teams to update SOPs, CAPA, change controls, and non-conformance investigations, while ensuring calibration and lab quality standards. This is a first-shift, onsite opportunity.

Qualifications

• Bachelor's degree in Biology, Biotechnology, Life Sciences, Chemistry or related field.
• Experience in QA/QC or laboratory environment.
• Familiarity with GCP, ISO 17025, GMP preferred.
• Experience participating in audits and compliance activities.
• Strong understanding of QMS, CAPA, root cause analysis, and regulatory compliance.
• Proficiency with Microsoft Office applications.

Responsibilities

• Manage and maintain quality documentation and records within the Quality Management System (QMS).
• Support compliance with applicable quality standards and regulatory requirements.
• Assist with internal and external audits to ensure audit readiness and successful outcomes.
• Collaborate with cross-functional teams to develop, review, and update SOPs, work instructions, and quality guidelines.
• Support quality processes including CAPA, Change Control, Non-Conformance Investigations, Risk Management, and Root Cause Analysis.
• Review and approve customer projects for delivery.
• Support the qualification, maintenance, calibration, and control of laboratory instruments and equipment.
• Partner with internal stakeholders and external customers to ensure quality expectations are met.

Skills

Quality Assurance

Quality Control

Audit readiness

QMS

CAPA

Root Cause Analysis

MS Office

Regulatory compliance

Education

Bachelor's degree in Biology/ Life Sciences/ Chemistry

Tools

MS Office

Quality Systems (QMS)

Job description

Actalent is seeking a Quality Assurance Specialist for a contract role onsite in Waltham, MA. You will manage QA documentation, support regulatory compliance, and assist with audits to ensure readiness and successful outcomes.

You will collaborate with cross-functional teams to update SOPs, CAPA, change controls, and non-conformance investigations, while ensuring calibration and lab quality standards. This is a first-shift, onsite opportunity.