Technical Quality Assurance Senior Specialist

Technical Quality Assurance Senior Specialist

The Technical Quality Assurance Senior Specialist will oversee various quality aspects related to tech transfer and Process Performance Qualification (PPQ) activities. This role involves collaboration with Quality management to define and execute batch disposition strategies, ensuring comprehensive quality oversight throughout tech transfer processes.

Responsibilities

• Oversee quality aspects of tech transfer, including change control, supplier onboarding, analytical method transfer and validation, and document readiness.
• Collaborate with Quality management to define and execute batch disposition strategies, including involvement of Qualified Person (QP) as needed.
• Plan and execute Process Performance Qualification (PPQ) with quality oversight of strategy, protocol review and approval, and execution and closeout.
• Review and approve batch documentation before and after execution, including batch records, deviations, change controls, and test results.
• Coordinate with cross-functional groups for batch disposition activities and resolve related issues.
• Monitor and manage training, quality events, and change control records for timely completion.
• Support clinical drug product shipment, material transfer, and inventory management activities.
• Assist with Qualified Person (QP) and Authorized Person (AP) certification of product for required geographies.
• Archive documents in the eQMS system.
• Author, review, and approve documents and change control records.
• Manage document approvals using ZenQMS or Docusign.
• Participate in internal / external meetings and aid in risk mitigation and path-forward discussions.
• Assist with complaint investigations, internal audits, FDA response coordination, and regulatory inspection readiness.
• Support continuous improvement actions within the Quality Assurance department.
• Promote a culture of quality using risk-based decision making and escalate quality issues.

Essential Skills

Additional Skills & Qualifications

Work Environment

This position is fully remote, with an option for local candidates to work onsite if preferred. The work schedule is Monday through Friday during the first shift.

Job Type & Location

This is a Contract position based out of Boston, Massachusetts.

Pay and Benefits

The pay range for this position is $75.00 - $80.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 14, 2025.