Quality Assurance Associate

Job Title: Quality Assurance Specialist Job Description
The Quality Assurance Specialist ensures that biological products meet all quality, documentation, and regulatory standards by reviewing and approving product batch records and technical documentation, supporting investigations and continuous improvement initiatives, and auditing production processes for compliance with global and local procedures.
Responsibilities
- Review and approve product batch records and associated technical documentation to ensure completeness, accuracy, and compliance with internal procedures and regulatory requirements.
- Evaluate and approve documentation related to validation activities, deviations, change control activities, and media fills, ensuring that all quality and regulatory standards are met.
- Track, report, and define continuous improvement goals related to quality assurance and production processes.
- Investigate deviations and nonconformances, determine root causes, and support the development and implementation of effective corrective and preventive actions (CAPA).
- Communicate investigation findings, CAPA outcomes, and process improvements clearly and promptly to the Process Team and other relevant stakeholders.
- Audit production processes and laboratory activities for compliance with global and local procedures, regulatory guidelines, and internal quality standards.
- Create new or revise existing procedures and controlled documents as process or regulatory changes occur, ensuring documentation remains current and compliant.
- Develop training plans and deliver training to colleagues, including those outside the immediate area of responsibility, to ensure understanding and adherence to quality procedures.
- Qualify and mentor others in quality-related tasks, promoting consistent application of procedures and best practices.
- Demonstrate a strong understanding of regulations for various countries and provide informed input or approvals based on those regulatory requirements.
- Utilize electronic systems and applications such as Microsoft Office, SAP, Veeva, Learning One Source, and other relevant tools to manage documentation, training, and quality records.
- Contribute ideas to improve site performance and operational efficiency and work collaboratively with colleagues at all levels to implement improvements.
- Exercise sound judgment to assess the acceptability of product based on documentation provided, making decisions with minimal supervision when appropriate.
- Maintain a high level of professionalism in all interactions with internal and external customers, representing the quality function effectively.
- Apply strong attention to detail in all aspects of documentation review, auditing, and data entry to minimize errors and ensure data integrity.
Essential Skills
- Quality assurance experience in a biological production or similar regulated environment.
- Demonstrated knowledge of USDA and FDA regulatory requirements within a biological production setting.
- Understanding of core scientific principles in biology, chemistry, or related disciplines.
- Experience with CAPA processes, including root cause analysis and implementation of corrective and preventive actions.
- Proficiency with document control practices and management of controlled quality documentation.
- Familiarity with laboratory environments and processes, particularly in vaccine or biological product manufacturing.
- Ability to interpret and apply regulations for various countries in the context of product quality and documentation.
- Proficiency with Microsoft Office applications and other computer programs used in a regulated environment.
- Experience using SAP for data entry, tracking, or quality-related activities.
- Experience using Veeva or similar electronic quality or document management systems.
- Experience using Learning One Source or similar electronic learning and training management systems.
- Strong attention to detail and accuracy in reviewing and managing technical documentation.
- Ability to make informed decisions regarding product acceptability based on documentation and established criteria.
- Effective written and verbal communication skills for clear documentation, reporting, and cross-functional collaboration.
Additional Skills & Qualifications
- Associate's 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.
- Previous experience working in a biological production environment, ideally involving vaccines or similar products.
- Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided.
- Consistent demonstration of professionalism in interactions with internal and external customers.
- Proven ability to formulate new ideas for improving site performance and operational efficiency.
- Ability to work cohesively and collaboratively with colleagues at all levels of the organization.
- Curious mindset with a strong desire to understand processes and identify opportunities for improvement.
- Courage to raise concerns, challenge the status quo constructively, and support quality-focused decisions.
- Driven and self-motivated approach to work, with a focus on achieving high standards of quality and compliance.
Work Environment
This role operates in a regulated biological production and laboratory environment that emphasizes compliance, documentation accuracy, and collaboration across teams. The position follows a Monday through Friday schedule, typically from 2:00 p.m. to 10:00 p.m., requiring comfort with an afternoon to evening shift. Work involves frequent use of computer systems and electronic applications such as Microsoft Office, SAP, Veeva, and Learning One Source for documentation, training, and quality records management. The environment values professionalism, continuous improvement, and strong communication, with opportunities to interact closely with production, quality, and technical teams to support high-quality vaccine and biological product manufacturing.
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.
Job Type & Location
This is a Permanent position based out of Fort Dodge, IA.
Application Deadline
This position is anticipated to close on Nov 16, 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 [email protected] 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.