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Urgent! QA Deviation Investigator - Local Job Opening in Berkeley

QA Deviation Investigator



Job description

Job Title: QA Deviation Investigator
Job Description

As a QA Deviation Investigator, you will analyze and investigate deviations or non-conformances using problem-solving tools such as root cause analysis.

You will collect and analyze relevant data to identify patterns, trends, or potential causes, documenting your findings comprehensively and objectively.

Collaborating with various departments, you will gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).

You will also provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.

Additionally, you will participate in client communications and responses, working closely with program team leads, quality, and management.

Responsibilities

  • Analyze deviations or non-conformances using problem-solving tools like root cause analysis.
  • Collect and analyze data related to deviations to identify patterns, trends, or potential causes.
  • Document findings in a comprehensive and objective manner.
  • Collaborate with departments to gather information and implement corrective actions.
  • Provide timely written documentation of investigations.
  • Communicate recommendations based on investigation outcomes.
  • Participate in client communications and responses.
  • Essential Skills
  • Experience with CAPA, quality assurance, root cause analysis, and deviations.
  • Knowledge of pharmaceutical, GMP, and FDA regulations.
  • Technical writing and quality processes expertise.
  • Experience in a regulated environment, preferably in biologics/pharmaceuticals.
  • Additional Skills & Qualifications
  • Bachelor's degree in biology, biochemistry, chemistry, or a science-related field.
  • 1+ years of experience with problem-solving tools (Root Cause Analysis and/or LEAN/six sigma).
  • 1+ years of experience in technical writing and/or deviation writing.
  • 3+ years of experience in a regulated environment.
  • Solid technical writing and communication skills.
  • Ability to evaluate data and make recommendations based on trends.
  • Ability to work effectively in a fast-paced environment and prioritize tasks.
  • Ability to facilitate meetings for desired outcomes.
  • Work Environment

    The role requires working Monday through Friday, with flexibility in start and end times, although core hours are 9am to 3pm.

    This position involves collaborating with any department needed for deviations, not limited to upstream or downstream processes.

    Job Type & Location

    This is a Contract to Hire position based out of Berkeley, Missouri.

    Pay and Benefits

    The pay range for this position is $38.00 - $43.00/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 Berkeley,MO.

    Application Deadline

    This position is anticipated to close on Nov 7, 2025.


    Required Skill Profession

    Business Operations Specialists



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