Job Title: QA Deviation Investigator
Job Description

We are seeking a dedicated QA Deviation Investigator to analyze and investigate deviations or non-conformances using problem-solving tools like root cause analysis. You will collect relevant data, identify patterns, and document findings comprehensively. The role involves collaborating with various departments to implement corrective and preventive actions (CAPAs) and communicating recommendations based on investigation outcomes.

ResponsibilitiesAnalyze 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 SkillsExperience in CAPA, quality assurance, root cause analysis, deviations, pharmaceutical, GMP, FDA regulations.Proficiency in technical writing and quality processes.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.Additional Skills & QualificationsBS/BA in biology, biochemistry, chemistry, or other science-related field.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 role operates Monday to Friday from 8am-5pm, with flexibility in start and end times but must cover core hours from 9am-3pm. You will work with any department needed for deviations, not limited to upstream or downstream processes.

Pay and Benefits

The pay range for this position is $38.00 - $43.00

• 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 will be accepting applications until Dec 23, 2024.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.