Quality Assurance Associate

Actalent • Waltham, MA

65d • $25 - $27 • Onsite

About The Position

We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP processes, running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.

Requirements

• Quality assurance experience
• Document control
• Batch record review
• CAPA management
• Deviation handling
• Compliance with audits and quality systems management
• BS degree in a specific science with 3-5 years of experience
• Support for GMP requirements and compliance
• Knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines

Nice To Haves

• Experience supervising or managing direct reports

Responsibilities

• Support on-the-floor QA issues within the manufacturing suite.
• Mitigate gaps and risks for all quality and GMP processes.
• Run investigations for deviations, change controls, CAPAs, and out-of-specifications.
• Review and author SOPs.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the 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)

What This Job Offers

• Career Level: Mid Level
• Industry: Administrative and Support Services
• Number of Employees: 1,001-5,000 employees