Technical Quality Assurance Senior Specialist

Job Title: Technical Quality Assurance Senior Specialist

Job Description

The Technical Quality Assurance Senior Specialist will oversee and ensure the quality of tech transfer and process performance qualification (PPQ) activities. This role involves managing various quality aspects, including change control, supplier onboarding, analytical method transfer and validation, document readiness, and more. The position also requires collaboration with Quality management to define and execute batch disposition strategies and oversee PPQ planning, execution, and closeout.

Responsibilities

• Oversee quality aspects of tech transfer, including change control, supplier onboarding, and analytical method transfer and validation.
• Work with Quality management to define and execute batch disposition strategies, including Qualified Person (QP) involvement.
• Plan and execute Process Performance Qualification (PPQ), ensuring quality oversight of strategy, protocol review, manufacturing, testing execution, and closeout.
• Review and approve batch documentation before and after execution, including batch records, deviations, and change controls.
• Coordinate with cross-functional groups for batch disposition activities and resolve related issues.
• Monitor and manage training, quality event, and change control records to support timely completion of activities by functional and QA personnel.
• Support QA and Supply Chain personnel with clinical drug product shipment, material transfer, and inventory management activities.
• Support Qualified Person (QP) and Authorized Person (AP) certification of products for necessary geographies.
• Archive documents in the electronic Quality Management System (eQMS).
• Author, review, and approve documents and change control records as necessary.
• Initiate and manage document approvals in ZenQMS or Docusign.
• Assist with internal quality events such as CAPAs, Change controls, and Deviations.
• Participate in internal/external cross-functional meetings and provide aid with risk mitigation activities.
• Assist with tasks such as complaint investigation review/approval, internal audits, FDA response coordination, and regulatory inspection readiness.
• Promote a company-wide culture of quality using risk-based decision making and escalate quality issues and risks.
• Work with cross-functional teams to manage deliverables and timelines with minimal oversight.

Essential Skills

• Minimum of 5 years working experience in a quality assurance role in the biotech industry with experience in manufacturing and analytical testing.
• Experience working directly with 3rd parties (CDMOs and Contract Test Labs) including managing Quality records.
• Strong understanding of good manufacturing practice (GMP) requirements.
• Direct experience working with an electronic quality management system, with a preference for ZenQMS experience.
• Strong project management and organizational skills.
• Excellent analytical, problem-solving, and risk-based decision-making skills.

Additional Skills & Qualifications

• Bachelor’s degree preferred, but experience can substitute for education.
• Strong preference for candidates with direct experience in tech transfer of processes/methods and PPQ planning and execution.
• Preference for candidates with gene therapy experience.

Work Environment

This position is fully remote, with the option for local candidates to work onsite if preferred. The role operates on a Monday to Friday first shift schedule.

Job Type & Location

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

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.