Quality Control Director

Actalent, Inc.; Ames (IA); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k) plan

Job summary

Actalent, Inc. seeks a Quality Control Director in Ames, IA, to lead the QC department, directing on-site staff and ensuring compliance with USDA-CVB regulations.

The role involves hands-on benchwork, assay development, and documentation integrity for biologic product release testing. The ideal candidate will have advanced degrees in microbiology or related fields and experience in GLP/GMP environments, plus familiarity with animal health QC and regulatory submissions.

Qualifications

• Advanced degree in microbiology or related science is required.
• Experience in USDA-CVB regulated settings is strongly preferred.
• Experience in USDA-licensed animal health QC or laboratories is desirable.
• GLP or GMP environments experience is a plus.

Responsibilities

• Lead and manage the Quality Control department, providing direction and development for staff.
• Oversee benchwork including in vitro and in vivo assays for product release and potency testing.
• Ensure compliance with USDA regulations and 9 CFR requirements for biologic release testing.
• Review documentation and data to ensure accuracy and regulatory readiness.
• Coordinate sample shipping to USDA and preparation of submissions.
• Collaborate across cross-functional teams to drive projects to completion.
• Design studies, analyze data, and draw independent conclusions for release decisions.

Skills

In vitro immunoassay development

Aseptic technique

Microbiology

Cell culture

ELISA

SDS-PAGE

Western blotting

Data interpretation

Regulatory compliance

Project leadership

Education

BS/MS/PhD in Microbiology, Biology, Molecular Biology, or related scientific discipline

Job description

The Quality Control Director leads the Quality Control (QC) department, providing strategic direction, technical expertise, and hands-on support to ensure all testing and processes meet stringent regulatory standards. This role oversees in vitro and in vivo assays for product release, potency, and titer monitoring, and supports the growth of antigens for assay reagents. The director ensures full compliance with USDA regulations, drives continuous improvement in methods and processes, and maintains high standards of documentation accuracy and data integrity within an animal health laboratory environment.

Responsibilities

• Lead and manage direct reports in the Quality Control department, providing clear direction, performance feedback, and professional development.
• Provide mentorship to scientists, including on-site technical troubleshooting, guidance on experimental design, and support with complex laboratory challenges.
• Perform benchwork as needed, including in vitro and in vivo assays for product release, potency testing, titer monitoring, and growing antigens for assay reagents.
• Oversee all aspects of the Quality Control department, ensuring operational efficiency, scientific rigor, and adherence to established procedures.
• Ensure all testing, processes, and standard operating procedures (SOPs) comply with USDA regulations and relevant 9 CFR requirements for biologic product release testing.
• Identify opportunities to increase efficiency through improved methods and processes, including the evaluation and implementation of new techniques and workflows.
• Mitigate risk by developing and refining processes and methods that enhance quality, reliability, and regulatory compliance.
• Review documentation to ensure all records are completed accurately, thoroughly, and in accordance with internal and regulatory standards.
• Review data and bench records to verify the accuracy of results and the validity of conclusions, ensuring robust scientific interpretation.
• Conduct records review, including batch record and serial release document review, and coordinate shipping of samples to USDA and preparation of 2008 submissions.
• Collaborate effectively with cross-functional teams while also working independently to drive projects and initiatives to completion.
• Design studies and experiments, analyze data, and draw independent conclusions that inform product release decisions and process improvements.
• Work efficiently under pressure, manage multiple priorities, meet deadlines, and handle interruptions while maintaining high quality standards.
• Experience in a QC setting at an animal health company or USDA-CVB laboratory, with experience in USDA product release requirements.
• Extensive experience with in vitro immunoassay development, including assay design, optimization, and validation.
• Expert proficiency in aseptic technique, microbiology, and cell culture.
• Strong technical skills in ELISA, SDS-PAGE, and western blotting.
• Ability to design studies and experiments, analyze complex data sets, and form sound scientific conclusions independently.
• Ability to work efficiently under pressure, meet deadlines, and manage interruptions while maintaining accuracy and attention to detail.
• Ability to collaborate effectively with teams and also work independently as needed.

Additional Skills & Qualifications

• BS, MS, or PhD in Microbiology, Biology, Molecular Biology, or a related scientific discipline.
• Previous laboratory experience in a USDA-CVB regulated setting is strongly preferred.
• Experience working in a USDA-licensed animal health industry quality control setting or USDA laboratories.
• Experience with GLP or GMP environments is a plus.
• Previous experience working with laboratory animals is a plus, but not required.
• Strong appreciation for working in a family-owned, growth-oriented animal health company environment, including equine testing and expanding cattle product lines.

This is an onsite, first-shift role based in Ames, IA, working Monday through Friday.

Job Type & Location

This is a Permanent position based out of Ames, IA.

Pay and Benefits

The pay range for this position is $80000.00 - $120000.00/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.4 Weeks Paid Time Off each year.401K retirement plan.Health insurance coverage.Salary commensurate with experience.

Workplace Type

This is a fully onsite position in Ames,IA.

Application Deadline

This position is anticipated to close on Oct 5, 2026.

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.

We collect your phone number and email so that an Actalent representative can reach out to you regarding potential job opportunities. Please ensure that the phone number and email you provide are accurate, as an incorrect phone number or email may affect our ability to contact you.

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.