Quality Specialist

About the Role

Author and maintain reference standard certificates of analysis (CoAs) and specification documents. Plan, design, and oversee testing processes to ensure reference standards are fit for purpose and meet specifications, including characterization and requalification. Coordinate cross‑departmentally to manage incoming new reference materials for upcoming projects. Manage logistics of reference materials with contract labs, maintaining communication for characterization and testing. Perform on‑site and back‑office audits of reference standard usage, documentation, and compliance with regulatory requirements (FDA, ICH, EU, ISO). Provide QC review of documentation, data accuracy, and regulatory compliance for reference standard‑related processes. Assist in training QC personnel on handling, documentation, and regulatory requirements for reference standards. Act as liaison between Quality Control and other internal departments (AD, PM, MFG) for sample management, testing requirements, project documentation, and contract lab management.

Responsibilities

• Author and maintain reference standard CoAs and specification documents
• Plan, design, and oversee testing processes (characterization, requalification, etc.) to ensure reference standards meet specifications
• Coordinate with cross‑functional teams to manage incoming new reference materials for upcoming projects
• Manage logistics of reference materials with contract labs, maintaining communication for characterization and testing
• Perform on‑site and back‑office audits of reference standard usage, documentation, and regulatory compliance (FDA, ICH, EU, ISO)
• Provide QC review of documentation, data accuracy, and regulatory compliance for reference standard‑related processes
• Assist in training QC personnel on handling, documentation, and regulatory requirements for reference standards
• Act as liaison between Quality Control and internal departments (AD, PM, MFG) for sample management, testing requirements, project documentation, and contract lab management

Requirements

• BS in Chemistry (or related) with 5+ years in a GMP lab, or MS with 3+ years
• Strong communication, collaboration, and attention to detail
• Solid understanding of reference standard specifications and scheduling
• Working knowledge of SQL, databases, and data integrity principles (ALCOA+)
• Understanding of Smartsheet and audit readiness

Skills

• Quality control
• Chemistry
• Reference material management
• Chemistry testing
• Characterization
• Certificate of Analysis (COA)
• GMP
• FDA, ICH, EU, ISO regulatory knowledge

Pay

$38.00 – $40.00 per hour

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan (pre‑tax and Roth post‑tax contributions)
• Life Insurance (Voluntary Life & AD&D for employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job Details

Contract position, fully onsite in Milford, MA. Intermediate experience level.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.