• Senior Sterility Quality Associate

    Actalent (Fort Dodge, IA)


    Job Title: Senior Sterility Quality Associate

    Job Description

    As a Senior Sterility Quality Associate, you will play a crucial role in leading and contributing to the sterility assurance and contamination control team. You will collaborate with production and other teams to ensure that analytical processes meet sterility assurance standards aligned with GMP and regulatory expectations. Your focus will be on improving site sterility assurance processes, which includes aseptic training, qualifications, and environmental monitoring.

    Responsibilities

    + Act as the primary expert in contamination control, aseptic processing, and sterilization.

    + Provide guidance and support to manufacturing operations, ensuring compliance with regulatory requirements and industry best practices.

    + Lead the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance.

    + Assist in aseptic processing, media fills, and sterilization cycle validation.

    + Conduct root cause analyses and implement corrective actions to minimize process risks and optimize productivity.

    + Develop and deliver sterility assurance training programs for personnel.

    + Ensure compliance with all regulations and industry standards during audits and inspections.

    Essential Skills

    + Proficiency in quality assurance, biology, microbiology, and sterility assurance.

    + Expertise in aseptic process simulation, aseptic processing, and sterile processing.

    + Experience with poultry vaccine technologies, protein platforms, and cell culture and fermentation technology.

    Additional Skills & Qualifications

    + Bachelor's or Master's degree in Microbiology, Biology, or a related scientific field.

    + 3-5 years of experience in a related field.

    + Strategic mindset with experience in particle monitoring, guidance documentation, evaluations, and project implementation.

    + Familiarity with FDA, USDA, and GMP regulations.

    + Preferred qualifications: experience with upstream production of viruses in cell monolayers, bioreactors, and fermenters; knowledge of lean manufacturing and six sigma.

    Work Environment

    This role involves a balanced work environment, with 50% of the time spent on the floor and 50% in an office setting. The position follows a Monday-Friday schedule, starting at 8 AM. Employees enjoy impactful work in the animal world, positively affecting livestock and pets. The company offers generous benefits upon full-time conversion, including paid shutdowns, parental leave, employee resource groups, annual bonuses, 401K matching, and PTO.

    Pay and Benefits

    The pay range for this position is $45.00 - $55.00/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 Fort Dodge,IA.

     

    Application Deadline

     

    This position is anticipated to close on Jun 3, 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.