• Technical Quality Assurance Senior Specialist

    Actalent (Boston, MA)


    Job Title: Technical Quality Assurance Senior SpecialistJob Description

     

    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

    + Minimum of 5 years working experience in a quality assurance role in the biotech industry with manufacturing and analytical testing experience.

    + Experience working directly with 3rd parties such as CDMOs and Contract Test Labs.

    + Strong preference for candidates with experience in tech transfer of processes/methods and PPQ planning and execution.

    + Strong understanding of good manufacturing practice (GMP) requirements.

    + Experience with electronic quality management systems, preferably ZenQMS.

    + Strong project management and organizational skills.

    + Excellent analytical, problem-solving, and risk-based decision-making skills.

    Additional Skills & Qualifications

    + Bachelor’s degree preferred, but relevant experience can substitute for education.

    + Preference for candidates with gene therapy experience.

    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.

    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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.