Job Title: QA Deviation Investigator

Job Description

We are seeking a QA Deviation Investigator to analyze and investigate deviations or non-conformances within our organization. The successful candidate will utilize problem-solving tools such as root cause analysis to identify patterns and trends, document findings accurately, and collaborate with various departments to implement corrective and preventive actions (CAPAs). This role requires effective technical writing skills and the ability to work in a fast-paced environment.

Responsibilities

• Analyze and investigate deviations or non-conformances using root cause analysis.
• Collect and analyze relevant data to identify patterns, trends, or potential causes.
• Document findings comprehensively and objectively, ensuring accurate recording of all relevant information.
• Collaborate with various departments to gather information, evaluate causal factors, and implement 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 with CAPAs, quality assurance, root cause analysis, and deviations.
• Knowledge of pharmaceutical GMP and FDA regulations.
• Experience in manufacturing and laboratory investigations.
• Proficiency in technical writing and quality processes.
• Experience with six sigma methodologies.

Additional Skills & Qualifications

• BS/BA in biology, biochemistry, chemistry, or other science-related field.
• 1 years of experience utilizing problem-solving tools (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.
• 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 core hours must be worked between 9am-3pm. The position will involve collaboration with various departments as needed for handling deviations, without being limited to any specific department such as upstream or downstream.

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 Feb 7, 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.

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.

Salary : $38 - $43