• Quality Investigator

    Actalent (North Billerica, MA)


    Job Title: Quality InvestigatorJob Description

     

    Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform thorough root cause analyses and collaborate cross-functionally to gather data and ensure accurate, complete, and timely investigation reports.

    Responsibilities

    + Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations.

    + Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress.

    + Author and review investigation reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness.

    + Monitor and track investigation metrics to identify systemic issues and recommend process improvements.

    + Support regulatory inspections and internal audits by presenting investigation documentation and participating in discussions with auditors.

    + Mentor junior investigators and provide training on investigation techniques and quality system requirements.

    Essential Skills

    + Quality assurance

    + Investigator

    + Root cause analysis

    + CAPA

    + Deviation management

    + Investigation

    + Compliance

    + Document control

    Additional Skills & Qualifications

    + Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.

    + Minimum 8–10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment, with at least 5–7 years focused on deviation management and investigations.

    + Strong knowledge of cGMP, ICH Q10, FDA, EMA, and other global regulatory requirements.

    + Demonstrated expertise in root cause analysis and CAPA development.

    + Proficiency in quality systems software (e.g., TrackWise) is preferred.

    Work Environment

    The role requires working Monday through Friday, 100% onsite in Billerica, MA. You will be part of the tech operations team supporting quality.

    Pay and Benefits

    The pay range for this position is $80.00 - $95.00/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 onsite position in North Billerica,MA.

     

    Application Deadline

     

    This position is anticipated to close on Jun 12, 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.