Quality Assurance - Process Team

ACTalent; Fort Dodge (IA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Paid vacations and holidays

401K retirement plan

Job summary

Actalent in Fort Dodge, IA is seeking a Quality Assurance Subject Matter Expert to lead deviation investigations, manage CAPA, and ensure robust documentation across pharmaceutical and vaccine manufacturing. The role requires strong regulatory knowledge (FDA/USDA), hands-on QA practices, and proficiency with Veeva; you will drive RFT improvements, support inspections, and help train teams.

This permanent, on-site position offers a daytime shift, competitive pay, benefits, and opportunities to

Qualifications

• Associate degree or Bachelor's in science with relevant industry experience.
• Experience with pharmaceutical processes, vaccine manufacturing, or Quality Control.
• Hands-on QA practices including deviation management, root cause analysis, CAPA development, and document control.
• Knowledge of FDA/USDA regulatory expectations.
• Experience in laboratory or manufacturing settings related to pharmaceuticals or vaccines.
• Strong analytical thinking and problem-solving skills.

Responsibilities

• Lead complex deviation investigations from initiation to closure with root cause analysis.
• Provide guidance on impact assessments, change control, and quality records.
• Manage the lifecycle of quality records in Veeva with timely closure.
• Analyze quality metrics to drive continuous improvement and support Right First Time (RFT) manufacturing performance.
• Serve as SME during regulatory inspections and corporate audits with clear explanations of processes and records.
• Develop, revise, and implement SOPs related to quality systems and manufacturing operations.
• Contribute to training programs to build quality knowledge across teams.
• Support quality governance and inspection readiness with well-documented processes.
• Maintain document control practices ensuring accuracy and traceability.
• Collaborate with laboratory and production to address quality issues.

Skills

QA experience

Root cause analysis

Regulatory knowledge

Veeva experience

Technical writing

Analytical thinking

Laboratory experience

CAPA management

Deviations investigations

Education

Associate degree in science

Bachelor's degree in Biology or Chemistry

Tools

Veeva

Job description

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.

Application Deadline

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 ClearlyRated 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.

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 [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.