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Job Title: QA Deviation InvestigatorJob Description

As a QA Deviation Investigator, you will play a crucial role in analyzing and investigating deviations or non-conformances within a regulated environment. Utilizing problem-solving tools like root cause analysis, you will collect and analyze relevant data to identify patterns and potential causes. Your findings will be documented comprehensively, and you will collaborate with various departments to implement corrective and preventive actions (CAPAs). You will also participate in client communications and provide timely written documentation of investigations.

Responsibilities

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

+ Collect and analyze relevant data 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, and root cause analysis.

+ Knowledge of deviations in pharmaceutical settings and GMP/FDA regulations.

+ Strong technical writing and communication skills.

+ Proficiency in quality processes and Six Sigma methodologies.

Additional Skills & Qualifications

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

+ 1+ years of experience with problem-solving tools like 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, preferably in biologics/pharmaceuticals.

+ 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

The role requires working Monday through Friday, with core hours of 9am to 3pm, and flexibility in start and end times. You will collaborate with any department needed for deviations, not necessarily limited to upstream or downstream processes.

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 Jul 30, 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 [email protected] (%[email protected]) for other accommodation options.