QA Investigations & CAPA Specialist

Actalent • Berkeley, MO • 3h ago

QA Deviation Investigator

About the role

The QA Deviation Investigator plays a critical role in maintaining product quality and regulatory compliance within a pharmaceutical or biologics environment. In this position, you will investigate deviations and non-conformances, apply structured problem-solving methodologies, and drive meaningful corrective and preventive actions (CAPAs). Working cross-functionally, you'll help ensure high-quality outcomes, support client communications, and contribute to continuous improvement across quality systems.

If you enjoy analytical problem-solving, technical writing, and collaborating with diverse teams in a regulated setting, this role offers the opportunity to make a visible impact while building long-term expertise in quality assurance.

Key Responsibilities

Lead deviation and non-conformance investigations using structured problem-solving tools such as Root Cause Analysis, LEAN, and Six Sigma

Collect, review, and analyze investigation data to identify trends, patterns, and root causes

Document investigations clearly, objectively, and in full compliance with regulatory and internal quality requirements

Partner with cross-functional teams to evaluate causal factors and develop, implement, and track effective CAPAs

Deliver timely, high-quality investigation reports with clear conclusions and actionable recommendations

Support client communications related to deviations and investigations in collaboration with program team leads, QA, and leadership

Perform trend analysis to identify systemic issues and recommend improvements that reduce recurrence

Facilitate cross-functional meetings to drive alignment, clarify issues, and move investigations to closure

Manage multiple investigations simultaneously while meeting quality and timeline expectations

Share lessons learned and best practices to support continuous improvement of QA processes

Required Qualifications

BS/BA degree in Biology, Biochemistry, Chemistry, or another science-related field

1+ year of hands-on experience using Root Cause Analysis and/or LEAN/Six Sigma tools

1+ year of experience in technical writing and/or deviation writing

3+ years of experience working in a regulated environment (biologics or pharmaceuticals preferred)

Strong technical writing skills with the ability to produce clear, structured, and objective reports

Effective written and verbal communication skills for cross-functional and client interactions

Ability to analyze data, perform trend analysis, and make sound, evidence-based recommendations

Strong organizational skills with the ability to prioritize work in a fast-paced environment

Experience facilitating meetings and driving discussions toward clear outcomes

Working knowledge of QA principles, deviation management, GMP, and FDA expectations

Preferred Skills & Experience

Practical experience applying LEAN or Six Sigma methodologies to quality investigations or process improvements

Background in pharmaceutical, biologics, or other highly regulated life-science industries

Experience developing, implementing, and verifying the effectiveness of CAPAs

Comfort working across multiple functional areas and adapting to different @types of deviations

High attention to detail and a structured, methodical approach to documentation and problem solving

Interest in long-term career development within Quality Assurance or Deviation Investigation

Work Environment & Schedule

Full-time, Monday-Friday role

Standard hours: 8:00 a.m. - 5:00 p.m., with flexible start/end times as long as core hours (9:00 a.m. - 3:00 p.m.) are covered

Regulated pharmaceutical or biologics setting supporting multiple departments (not limited to upstream or downstream processing)

Highly collaborative environment working closely with Quality, Operations, and Program Teams

Opportunity for conversion to a permanent role, reflecting a strong commitment to long-term professional growth and integration into the quality culture

ACTjobsTFS2026

Job Type & Location

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

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 Apr 30, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

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