Quality Assurance SME

Actalent; Fort Dodge (IA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

401K retirement plan

Paid vacations and holidays

Job summary

Actalent is seeking a Quality Assurance SME to lead complex deviation investigations and manage quality records in Veeva during regulated pharmaceutical and vaccine manufacturing.

You will partner with Engineering, Production, and TSMS to mitigate risks, coach staff, and ensure SOPs and training materials meet FDA/USDA expectations, while driving continuous quality improvements.

Qualifications

• Quality-focused professional with strong documentation skills.
• Experience in regulated pharmaceutical manufacturing environments.
• Ability to interpret data and recommend compliant solutions.

Responsibilities

• Lead complex deviation investigations from initiation through closure.
• Own lifecycle of quality records in Veeva, including Change Controls and CAPAs.
• Represent Quality in meetings with Engineering, Production, and TSMS.
• Serve as SME during inspections by USDA and FDA.
• Review and update SOPs and training materials for regulatory alignment.
• Coach staff to strengthen quality culture on the floor.
• Provide clear technical documentation and investigation reports.
• Collaborate with lab, production, and engineering teams to apply QA principles.
• Support continuous improvement using quality data.

Job description

Job Title: Quality Assurance SME Job Description

The Quality Assurance SME leads complex quality investigations, drives continuous improvement, and serves as a key technical resource supporting regulated pharmaceutical and vaccine manufacturing operations. This role owns the full lifecycle of quality records within electronic systems, collaborates closely with cross-functional teams to mitigate process risks, and helps strengthen the overall quality culture through coaching, documentation, and participation in inspections.

Responsibilities

• Lead complex deviation investigations from initiation through closure, ensuring thorough root cause analysis and development of effective corrective and preventive actions (CAPAs).
• Own the complete lifecycle of quality records within Veeva, including creating, managing, and closing Change Controls, Impact Assessments, and Effectiveness Checks.
• Represent the Quality function in area huddles and routine meetings, partnering with Engineering, Production, and TSMS to identify, assess, and mitigate process risks.
• Serve as a primary technical resource and subject matter expert during internal, corporate, and regulatory inspections, including those conducted by USDA and FDA.
• Review, revise, and maintain standard operating procedures (SOPs) and training materials to ensure alignment with current processes and regulatory expectations.
• Provide coaching, guidance, and on-the-floor support to operational staff to enhance quality awareness and strengthen the site’s quality culture.
• Apply advanced critical thinking to analyze complex technical issues, interpret data, and recommend robust, compliant solutions.
• Produce clear, accurate, and well-structured technical documentation, including investigation reports and impact assessments.
• Collaborate with laboratory, production, and engineering teams to ensure quality assurance principles are consistently applied across processes.
• Support continuous improvement initiatives, leveraging quality data and lessons learned from investigations to prevent recurrence of issues.

Essential Skills

• Proven experience in pharmaceutical processes, vaccine manufacturing, or laboratory Quality Control.
• Strong quality assurance background, including deviation management, CAPA development, and document control.
• Advanced critical thinking skills with the ability to solve complex technical problems in a regulated manufacturing or laboratory environment.
• Strong technical writing skills, particularly for investigations, impact assessments, and other quality documentation.
• Working knowledge of USDA and FDA regulatory expectations in manufacturing settings.
• Foundational understanding of scientific disciplines such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry.
• Ability to collaborate effectively with cross-functional teams including Engineering, Production, TSMS, and laboratory staff.
• Demonstrated ability to represent Quality during audits and inspections, providing clear, confident responses to technical and compliance questions.

Additional Skills & Qualifications

• Bachelor’s degree in a science-related field such as Biology, Chemistry, Microbiology, Animal Science, Food Science, or Biochemistry, OR an Associate’s degree with relevant industry experience.
• Hands‑on experience with Veeva quality systems.
• Experience with SAP or similar enterprise resource planning systems.
• Prior experience working in a USDA or FDA regulated manufacturing environment.
• Knowledge of Lean and Six Sigma methodologies and their application to process improvement and defect reduction.
• Experience with CAPA management, change control processes, and effectiveness checks in a regulated setting.
• background in laboratory operations, vaccines, and quality control testing.
• Curious, courageous, and driven mindset, with a strong desire to continuously learn and improve processes.

Work Environment

This role operates in a regulated pharmaceutical and vaccine manufacturing environment that emphasizes strong quality standards and collaboration across Engineering, Production, TSMS, and laboratory teams. The typical work schedule is Monday through Friday, 7:30 a.m. to 4:30 p.m., offering a stable daytime shift. Work is performed in a mix of office and production or laboratory areas, with regular interaction with electronic quality systems such as Veeva and SAP and adherence to established SOPs and regulatory requirements. The environment supports continuous learning, cross-functional teamwork, and active participation in audits, inspections, and quality improvement initiatives.

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 - $95000.00/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.

Workplace Type

This is a fully onsite position in Fort Dodge,IA.

Application Deadline

This position is anticipated to close on Oct 4, 2026.

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 5\000 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.