Quality Assurance Specialist

Role Overview

This contract QA specialist position is centered on supporting a customer complaint management program. The role partners closely with customers, Commercial Operations, Technical Development, Regulatory Affairs, and MS&T to keep the complaint process running effectively. The position also helps maintain quality systems and governance, launches complaints and investigations, supports continuous GMP improvement, and may be responsible for building and updating data tracking tools used to oversee the program.

Key Responsibilities

• Open customer complaints and begin associated investigations.
• Support customer-facing teams, subsidiaries, wholesalers, distributors, and other stakeholders with troubleshooting and issue resolution.
• Track and evaluate complaint investigations handled by different contributors.
• Make sure subject matter experts carry out proper root cause analysis.
• Review complaint metrics so issues are categorized and investigated correctly.
• Maintain complaint records, study the data for patterns, and quickly flag high-risk or recurring systemic concerns.
• Oversee CAPAs tied to complaint investigations and confirm they are effective and completed within required timelines and commitments to health authorities and customers.
• Share investigation results with customers when requested.
• Watch customer feedback and satisfaction levels as needed.
• Facilitate cross-functional complaint-related meetings.
• Support escalations, market actions, and information requests as assigned.
• Handle projects delegated by leadership.

Requirements

• Bachelor’s degree in a life science or engineering field.
• 2 to 5 years of experience in biotechnology, medical devices, or pharmaceuticals.
• Strong ability to prepare technical investigation summaries for different audiences.
• Excellent written and verbal communication skills.
• Solid problem-solving capability.
• Very well organized with strong attention to detail.
• Self-driven and proactive.
• Comfortable using Microsoft Word, Excel, Visio, and PowerPoint.
• Ability to prioritize tasks and manage time effectively.

Additional Information

This is a contract role based onsite in Cambridge, Massachusetts. Compensation is listed at $50 to $55 per hour. The employer is an equal opportunity organization and considers applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, protected veteran status, or other legally protected status. Reasonable accommodations are available for candidates who need support during the application or interview process. Benefits mentioned include medical, prescription, dental, vision, AD&D, life insurance, short-term disability, and a 401(k), subject to eligibility. The posting remains open for 30 days.