• Biologics Quality Assurance Auditor

    Actalent (Columbus, OH)


    Biologics Quality Assurance Auditor

     

    INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA AT 330. 397. 1302 TO SET UP A PHONE INTERVIEW!

    Job Description

    The Quality Assurance (QA) Auditor provides compliance and quality improvement support for the manufacture of phase 1/2a Investigational New Drug, Biologics manufacturing, and facility operations. This role works alongside the Quality Assurance Manager to plan, schedule, and conduct audits as well as administrative tasks to support the quality management program. The QA Auditor ensures the biologics manufacture and facility adhere to applicable regulations, policies, procedures, and expectations of phase-appropriate current Good Manufacturing Practices (cGMP). Additionally, the QA Auditor participates in various quality and process improvement initiatives as directed by the Quality Assurance Manager.

    Responsibilities

    + Operate within the Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices.

    + Maintain current knowledge of applicable phase-appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.

    + Lead data review processes to facilitate biologic IND product release.

    + Perform GMP and Good Documentation Practices training for manufacturing and support personnel.

    + Lead QA functions related to Quality programs such as process, laboratory audits, protocol approvals, etc., as assigned.

    + Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits.

    + Support the QA Manager in mentoring and training QA staff as needed.

    + Assist the QA Manager during client and regulatory audits, and in client audits for records review.

    + Manage, review, and approve controlled documents necessary for effective functioning of biologics manufacture and good tissue practices.

    + Provide additional support to the Quality Assurance Manager as required.

    Essential Skills

    + Bachelor’s degree in a scientific discipline with a minimum of 3 years of quality or regulatory experience.

    + Knowledge and expertise in the principles of Pharmaceutical Good Manufacturing Practices (GMP).

    + Proficient computer skills, including Microsoft Office Suite, SharePoint, and Quality Management Systems.

    + Experience in conducting audits and technical writing.

    + Ability to guide and train QA staff in various tasks.

    + Willingness to travel for vendor/supplier audits and trainings (approximately 15%).

    + Strong interpersonal, organizational, and leadership skills.

    + Ability to manage multiple tasks simultaneously in a growing department.

     

    Additional Skills & Qualifications

     

    + Prior experience in technical writing is preferred.

    Work Environment

    The culture is very team-oriented, with a diverse group of individuals continuing to grow. The team currently comprises around 4 individuals, working in collaboration with other teams totaling approximately 23 people, with plans to expand further by the end of the year. Collaboration is essential as no work or testing is conducted alone. Work hours are 1st shift, Monday to Friday, 8:00 AM to 4:30 PM, with occasional overtime.

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Columbus, OH.

    Pay and Benefits

    The pay range for this position is $28.00 - $30.00/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 Columbus,OH.

     

    Application Deadline

     

    This position is anticipated to close on Jan 1, 2026.

    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.