• Quality Assurance Technician

    Actalent (Vandalia, OH)


    Job Title: Quality Assurance Technician

    Job Description

    The Quality Assurance Technician will perform quality control inspection and disposition of materials and products according to established specifications. This role ensures compliance with applicable FDA, state OSHA, and ISO regulations and standards by performing QC inspections using measuring instruments and inspection methods. The technician will identify and manage non-conforming materials or products in accordance with the Quality System and perform a variety of tasks under limited supervision.

    Responsibilities

    + Perform reviews of batch production records and manufacturing records as part of lot release activities.

    + Coordinate and track CAPA, NCR, and Deviation records, ensuring timely completion of tasks.

    + Coordinate and track the site environmental monitoring (EM) testing program.

    + Assist teams in problem solving and root cause analysis for quality events.

    + Develop, review, and release quarterly EM trending reports and bring significant trends to management attention.

    + Provide input based on knowledge and experience with batch release requirements.

    + Support QMS Operations related activities for all CGMP departments.

    + Conduct Quality Control activities at processing or distribution sites, including inspections of incoming materials, in-process, and finished products.

    + Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.

    + Support gowning qualification and training.

    + Ensure timely issuance, review, and approval of Microbiology and EM testing results.

    + Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies.

    + Assist in the review and approval of equipment qualifications.

    + Assist in the review of Calibration and Preventative Maintenance reviews.

    + Assist in hosting onsite regulatory audits and inspections.

    Essential Skills

    + Bachelor’s Degree in a Life Science discipline or related field.

    + 1-2 years of relevant industry experience with GMP, GDP, or GXP, within a Medical Device, Pharmaceutical, or Tissue commercial organization.

    + Experience in an FDA-regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing.

    + Proficiency in Microsoft Excel.

    + Experience writing Standard Operating Procedures and Work Instructions.

    + Familiarity with Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations.

     

    Additional Skills & Qualifications

     

    + Knowledge in biology, human tissue, skin processing, and compliance.

    Work Environment

    The position is primarily desk-based with some inspection duties and occasional work in clean rooms or labs. Candidates should be comfortable working around human tissue. Work hours are flexible and may include shifts: 1st shift Monday-Friday 7:00 AM-3:30 PM, and 2nd shift Monday-Friday 3:00 PM-11:30 PM. The work setting includes a brand-new, state-of-the-art facility in Vandalia, OH, reflecting a company experiencing rapid growth.

     

    Job Type & Location

     

    This is a Contract position based out of Vandalia, OH.

    Pay and Benefits

    The pay range for this position is $26.50 - $26.50/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 Vandalia,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.