• QC Microbiology Data Reviewer

    Actalent (Indianapolis, IN)


    QC Microbiology Data Reviewer opportunity

     

    Interview availability Monday 12/22 and Tuesday 12/23

     

    Reach out to Grace Williams directly to apply | grawilliams @actalentservices.com | 317 - 567 - 6610

    Job Description

    We are seeking a QC Microbiology Data Reviewer to join our team. The ideal candidate will perform comprehensive reviews of QC microbiology data to ensure completeness, accuracy, and compliance with cGMP standards. This role involves verifying raw data, calculations, and instrument outputs, ensuring all documentation adheres to ALCOA+ data integrity principles.

    Responsibilities

    + Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance.

    + Verify raw data, calculations, and instrument outputs for assays including bioburden, sterility, endotoxin, media qualification, and environmental monitoring.

    + Confirm adherence to SOPs, test methods, and approved protocols.

    + Ensure documentation meets ALCOA+ data integrity principles.

    + Identify discrepancies or errors and work with analysts to resolve issues and ensure right the first-time documentation.

    + Review environmental monitoring results and escalate any out-of-trend or excursion findings.

    + Write deviations, CAPAs, and revise SOPs as needed.

    + Compose monthly and quarterly reports for environmental monitoring.

    + Support internal and external audits by providing clear, compliant documentation.

     

    Qualifications & Skills

     

    + Must have minimum 4 years’ experience in GMP microbiology laboratory and quality data review.

    + Experience and knowledge in Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring.

    + Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.

    + Experience with Sherpa or other LIMS, and MS SharePoint Experience

    + SAP experience preferred.

    + Technical knowledge of assays to determine corrections.

    + Ability to direct next steps for actions using data.

    + Self-starter with a sense of urgency to complete tasks accurately.

    Education

    + Bachelor’s degree in Microbiology, Biology, or Biotechnology or equivalent highly preferred.

    + Preferred training in Quality systems, cGMP, and Data Integrity.

     

    INTERESTED IN THIS ROLE? SEE BELOW TO APPLY NOW FOR IMMEDIATE CONSIDERTATION:

     

    + I am scheduling interviews for this position and conducting phone interviews as early as today. All candidates will be considered immediately within 24 hours of applying directly to Grace Williams.

    + HOW TO APPLY DIRECTLY: Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to grawilliams@actalentservices. com and/or CALL/TEXT ME: 317 567 6610

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Indianapolis, IN.

    Pay and Benefits

    The pay range for this position is $40.00 - $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 Indianapolis,IN.

     

    Application Deadline

     

    This position is anticipated to close on Jan 2, 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.