Quality Assurance - Process Team

Job Title:

Quality Assurance Subject Matter Expert
Responsibilities

• Lead complex deviation investigations from initiation through closure, ensuring thorough root cause analysis and robust, effective CAPA development.
• Provide technical guidance on impact assessments, change control activities, and other quality records to ensure compliance and operational excellence.
• Own and manage the lifecycle of quality records within Veeva, including creation, review, prioritization, and timely closure with technically sound documentation.
• Analyze quality metrics and trends to drive continuous improvement initiatives and support Right First Time (RFT) manufacturing performance.
• Serve as a Quality Subject Matter Expert during regulatory inspections and corporate audits, providing clear explanations of processes, records, and decisions.
• Support the development, revision, and implementation of Standard Operating Procedures (SOPs) related to quality systems and manufacturing operations.
• Contribute to training programs by sharing quality expertise and helping build quality and compliance knowledge across functional teams.
• Participate in quality governance activities and support overall inspection readiness, ensuring documentation, processes, and facilities remain audit-ready.
• Maintain strong document control practices and ensure quality records meet regulatory and internal standards for accuracy, completeness, and traceability.
• Collaborate with laboratory and production personnel to address quality issues related to pharmaceutical processes and vaccine manufacturing.

Essential Skills

• Associate degree in a science-related field with relevant industry experience, or a Bachelor's Degree in a science-related field such as Biology or Chemistry.
• Demonstrated technical depth in pharmaceutical processes, vaccine manufacturing, or Quality Control, including experience with complex investigations and impact assessments.
• Hands-on experience with quality assurance practices, including deviation management, root cause analysis, CAPA development, and document control.
• Working knowledge of regulatory expectations in environments governed by agencies such as FDA and USDA.
• Experience supporting or working within laboratory or manufacturing settings related to pharmaceuticals or vaccines.
• Advanced critical thinking and analytical problem-solving skills to evaluate complex issues and propose effective solutions.
• Strong technical writing skills with the ability to produce clear, accurate, and compliant quality documentation and reports.
• Ability to act as a subject matter expert during regulatory inspections and corporate audits, explaining quality systems and records confidently.
• Proficiency in using electronic quality systems such as Veeva for managing and maintaining quality records.

Work Environment
The role follows a Monday through Friday first-shift schedule, providing regular daytime working hours.
Job Type & Location
This is a Permanent position based out of Fort Dodge, IA.
Pay And Benefits
The pay range for this position is $65000.00 - $85000.00/yr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Paid vacations and holidays. 401K retirement plan. Health insurance coverage.
Job Type & Location
This is a Permanent position based out of Fort Dodge, IA.
Final date to receive applications
This position is anticipated to close on Nov 13, 2026.
Workplace Type
This is a fully onsite position in Fort Dodge,IA.
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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a Clearly Rated Best of Staffing winner for both client and talent service.
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.
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