Quality Control Director

Iowa Ag

Fort Dodge (IA)

On-site

USD 120,000 - 150,000

Full time

7 days ago
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Job summary

Elanco, a global animal health leader, seeks a Quality Control Director to oversee chemistry, virology, and immunochemistry QA operations in Fort Dodge, IA. You will ensure compliance with cGMP/GLP, manage CAPA responses, and drive SOP development and training.

The role requires a Master’s in a relevant field and at least 3 years in a regulated pharma environment, with strong leadership and budgeting skills to support audits and continuous improvement.

Qualifications

  • Master's degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related field plus 3 years experience in a regulated pharma environment.
  • Experience with cGMP/GLP, documentation practices, change management, and sample control.
  • Proven ability to lead QA teams, investigate root causes, and develop CAPA actions.

Responsibilities

  • Provide administrative and technical leadership to Quality Control teams overseeing chemistry, virology, immunochemistry, and other lab functions.
  • Ensure QA operations comply with corporate and regulatory requirements; support internal departments and external partners.
  • Develop and maintain SOPs; lead CAPA investigations and cross-functional root-cause analysis.

Skills

Lean/Six Sigma
CAPA oversight

Education

Master's degree in Biology/ Chemistry/ Biochemistry/ Biopharmaceuticals (or related)

Tools

SOP writing

Job description

#### Job Title:Quality Control Director #### Location:Fort Dodge, IA, Midwest United States,USA #### Company:Elanco #### Industry Sector:Agribusiness #### Industry Type:Input Retail, Cooperative and Related Crop Services #### Career Type:Quality Assurance #### Job Type:Full Time #### Minimum Years Experience Required:N/A #### Salary: ### Get Job Alerts**Career Type:** Quality Assurance **Country:** USAI agree to receive alerts from AgCareers.com and to the Terms of Service.# Quality Control DirectorBack to search resultsApply to this positionFollow CompanyMore Jobs from ElancoSend to Friend**At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals' lives better makes life better - join our team today!** **Your day-to-day will include:** * Provide both administrative and technical leadership to Quality Control teams overseeing Chemistry, Virology, Immunochemistry, and other key laboratory functions.* Manage all quality control operations, to ensure full compliance with corporate and regulatory requirements while effectively supporting internal departments and external partners.* Provide quality oversight to the Quality Department and site, ensuring compliance with documentation practices, change management, sample control, laboratory systems, and laboratory investigations.* Support audit responses and ensure timely completion of assigned Corrective and Preventive Action (CAPA).* Develop and maintain Standard Operating Procedures (SOPs) and training programs related to sample control and accountability.* Proactively identify and mitigate risks to quality control processes, including analytical chemistry and biochemistry test methods, ensuring their ongoing maintenance, validation, and improvement.* Implement process improvements to maintain a high-performing, efficient laboratory environment.* Oversee quality control investigations involving chemical and immunochemical assays by ensuring employee training, reviewing reports for scientific and regulatory compliance, and facilitating cross-functional root cause analysis and CAPA development.* Supervises 5 subordinates - Manager Quality Control 1. **You have the following technical skills and qualifications:** * Requirement - Master's degree in Biology, Chemistry, Biochemistry, Biopharmaceuticals, or related, or foreign equivalent plus 3 years post-baccalaureate experience in job offered or any related quality control related job titles.* Relevant experience - Applicants must possess at least 3 years of experience in the following: (1) Working in a regulated pharmaceutical/vaccine manufacturing environment; (2) regulatory requirements, inclusive of cGMP/GLP and ensuring compliance with documentation practices, change management, and sample control; (3) Investigation techniques including providing technical guidance, training, and oversight for testing vaccines in a Vaccine manufacturing environment; (4) Conducting root cause analysis and identifying, developing, and tracking Corrective and Preventive Actions (CAPA), including in support of audit responses; (5) preparation, monitoring, and adherence of departmental budgeting; (6) Lean/5S/six sigma methodologies; (7) laboratory control operations; and (8) Developing and maintaining Standard Operating Procedures (SOPs) and validating, maintaining, and improving analytical chemistry and biochemistry test methods. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.To apply please click on APPLY TO THIS POSITIONApply to this positionSave this jobJob Post Date: 10/21/26
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