QA Deviation Investigator

Actalent • Berkeley, MO • 3h ago

Job Description

The QA Deviation Investigator is responsible for analyzing and investigating deviations or non-conformances within the organization. The role involves using problem-solving tools like root cause analysis, collecting and analyzing data to identify patterns, trends, or potential causes, and documenting findings comprehensively. This position requires collaboration with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs). Additionally, the investigator will provide timely written documentation of investigations and communicate recommendations based on investigation outcomes. Participation in client communications and responses, working closely with program team leads, quality, and management is also expected.

PAY - $36-$40/hour

Responsibilities

Analyze and investigate deviations or non-conformances using problem-solving tools like root cause analysis.

Collect relevant data and information related to deviations, and analyze it to identify patterns, trends, or potential causes.

Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.

Collaborate with various departments to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).

Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.

Participate in client communications and responses, working closely with program team leads, quality, and management.

Essential Skills

Experience in CAPA, quality assurance, root cause analysis, deviations, pharmaceutical, GMP, FDA, deviations and root cause analysis.

Technical writing proficiency.

Knowledge of quality processes and six sigma methodologies.

Additional Skills & Qualifications

BS/BA in biology, biochemistry, chemistry, or other science-related field.

1+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.

1+ years of experience in technical writing and/or deviation writing.

3+ years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.

Solid technical writing and communication skills.

Ability to evaluate data and make recommendations based on trends and trend analysis.

Ability to work effectively in a fast-paced environment and prioritize tasks.

Ability to facilitate meetings for desired outcomes.

Work Environment

This position requires working Monday-Friday from 8am-5pm with flexibility in start and end times, but core hours of 9am-3pm must be adhered to. The role involves collaboration with any department necessary for addressing deviations, not limited to upstream or downstream processes.

Job Type & Location

This is a Contract position based out of Berkeley, MO.

Pay and Benefits

The pay range for this position is $36.00 - $40.00/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 Feb 26, 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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