QA Deviation Investigator

Job Title: QA Deviation Investigator Job Description
The QA Deviation Investigator analyzes and investigates quality deviations and non-conformances in a regulated pharmaceutical or biologics environment. This role uses structured problem-solving tools such as root cause analysis, LEAN, and Six Sigma to identify causes, recommend effective corrective and preventive actions (CAPAs), and ensure thorough documentation of findings. The investigator collaborates closely with cross-functional teams and quality stakeholders to drive continuous improvement and support compliant, reliable operations.
Responsibilities
- Analyze and investigate deviations and non-conformances using structured problem-solving tools such as root cause analysis and LEAN/Six Sigma methodologies.
- Collect relevant data and information related to deviations, and analyze it to identify patterns, trends, and potential root causes.
- Document investigation findings in a comprehensive, objective, and clear manner, ensuring accurate recording of all relevant information.
- Develop, recommend, and support implementation of corrective and preventive actions (CAPAs) based on investigation outcomes.
- Collaborate with various departments to gather information, evaluate causal factors, and align on effective CAPAs and process improvements.
- Provide timely written documentation of investigations, including summaries, conclusions, and recommendations for preventing recurrence.
- Communicate investigation results and recommendations to stakeholders, including program team leads, quality representatives, and leadership.
- Participate in client communications and responses related to deviations and investigations, ensuring professional and clear representation of findings.
- Facilitate meetings and discussions to drive consensus on root causes, CAPAs, and timelines for completion.
- Evaluate data trends from deviations and investigations to identify systemic issues and opportunities for continuous improvement.
- Work with any department that requires deviation support, adapting to different processes and operational areas as needed.
- Prioritize multiple investigations and tasks in a fast-paced environment while meeting established deadlines and quality standards.
Essential Skills
- BS/BA degree in biology, biochemistry, chemistry, or another science-related field.
- At least 1 year of experience directly using problem-solving tools such as Root Cause Analysis and/or LEAN/Six Sigma with demonstrated success.
- At least 1 year of experience in technical writing and/or deviation writing.
- At least 3 years of experience working in a regulated environment, preferably in biologics or pharmaceuticals.
- Strong technical writing skills with the ability to produce clear, accurate, and concise investigation reports.
- Solid communication skills, both written and verbal, to effectively interact with cross-functional teams and clients.
- Ability to evaluate data, perform trend analysis, and make informed recommendations based on findings.
- Ability to work effectively in a fast-paced environment and prioritize tasks to meet deadlines.
- Ability to facilitate meetings and guide teams toward desired outcomes during investigations and CAPA discussions.
- Working knowledge of quality assurance principles, deviations, CAPA processes, and regulatory expectations in GMP environments.
- Familiarity with FDA-regulated environments and Good Manufacturing Practices (GMP).
Additional Skills & Qualifications
- Experience with LEAN and/or Six Sigma methodologies applied to deviation investigations and process improvement.
- Experience conducting deviations and root cause analysis in pharmaceutical or biologics manufacturing environments.
- Exposure to quality processes and systems that support investigation management and CAPA tracking.
- Comfort collaborating with multiple departments and adapting to different operational areas as deviation needs arise.
- Interest in long-term opportunities, with potential for contract extension or conversion based on performance and business needs.
Work Environment
This role operates in a regulated pharmaceutical or biologics environment with a strong focus on quality, compliance, and continuous improvement. The typical schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., with flexibility in start and end times, provided core hours of 9:00 a.m. to 3:00 p.m. are covered. The QA Deviation Investigator supports any department that requires deviation investigation support, rather than being limited to a specific area such as upstream or downstream operations. The position is offered as a 6-month contract with the possibility of extension and potential conversion, providing an opportunity to contribute meaningfully to quality initiatives while working alongside cross-functional teams in a professional, fast-paced setting.
Job Type & Location
This is a Contract position based out of St. Louis, MO.
Pay and Benefits
The pay range for this position is $38.00 - $43.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Oct 12, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.