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QA Deviation Investigator

Actalent
locationSt. Louis, MO, USA
PublishedPublished: 6/14/2022
Legal
Full Time

Job Description

Job DescriptionJob Title: QA Deviation InvestigatorJob 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 be responsible for collecting relevant data and information related to deviations, analyzing it to identify patterns, trends, or potential causes, and documenting findings in a comprehensive and objective manner.

Responsibilities

  • Analyze and investigate deviations or non-conformances using problem-solving tools like root cause analysis.
  • Collect and analyze relevant data to identify patterns, trends, or potential causes of deviations.
  • Document findings accurately and comprehensively.
  • Collaborate with various departments to gather information and implement corrective and preventive actions (CAPAs).
  • Provide timely written documentation of investigations and communicate recommendations based on outcomes.
  • Participate in client communications and responses, working closely with program team leads, quality, and management.


Essential Skills

  • Experience in CAPA, quality assurance, and root cause analysis.
  • Knowledge of deviations, pharmaceutical regulations, GMP, and FDA standards.
  • Proficiency in technical writing and quality processes.
  • Experience in Six Sigma methodologies.


Additional Skills & Qualifications

  • BS/BA in biology, biochemistry, chemistry, or a related science field.
  • 1+ years of experience using problem-solving tools such as Root Cause Analysis or LEAN/Six Sigma.
  • 1+ years of experience in technical writing or deviation writing.
  • 3+ years of experience working in a regulated environment, preferably in biologics or pharmaceuticals.
  • Strong technical writing and communication skills.
  • Ability to evaluate data, recognize trends, and make informed recommendations.
  • Ability to work effectively in a fast-paced environment and prioritize tasks.
  • Ability to facilitate meetings for desired outcomes.


Work Environment

The work schedule is Monday to Friday, from 8am to 5pm, with flexibility in start and end times but core hours of 9am to 3pm must be maintained. This role involves collaboration with any department needed for handling 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 St. Louis,MO.

Application Deadline

This position is anticipated to close on Sep 29, 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 actalentaccommodation@actalentservices.com for other accommodation options.

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