Quality Control Director - Lead Compliance & Lab Excellence

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

Benefits offered by this job

Health insurance

401K retirement plan

Paid vacations and holidays (4 weeks P

Job summary

Actalent in Ames, IA is seeking a Quality Control Director to lead the QC department in an animal health laboratory, ensuring testing and release activities meet USDA 9 CFR standards. This is an onsite, permanent role with opportunities to drive continuous improvement and cross-functional collaboration.

The role combines strategic leadership with bench work in ELISA, cell culture, and data integrity, emphasizing robust documentation and regulatory compliance.

Qualifications

• BS/MS/PhD in Microbiology or related science with USDA-CVB regulated lab experience.
• 7+ years in quality control in animal health or USDA labs.
• In vitro immunoassay development, validation and optimization experience.
• Proven leadership managing a QC team.
• Knowledge of 9 CFR requirements for biologic product release testing and related memos.

Responsibilities

• Lead and manage the QC department with clear direction and performance feedback.
• Mentor scientists with on-site troubleshooting and experimental design guidance.
• Perform benchwork including in vitro/in vivo assays for product release and titer monitoring.
• Ensure all testing, SOPs, and records comply with USDA regulations.
• Identify efficiency opportunities and implement new methods and workflows.
• Review batch records and documentation for accuracy and regulatory compliance.
• Coordinate sample shipments to USDA and assist with submissions as needed.
• Collaborate cross-functionally and manage multiple priorities under pressure.

Skills

QC leadership

USDA/9 CFR knowledge

Immunoassay development

Aseptic technique & cell culture

ELISA/SDS-PAGE/Western blot

Documentation & batch release

Team mentoring

Education

BS/MS/PhD in Microbiology/Biology/Molecular Biology or related

Job description

Actalent in Ames, IA is seeking a Quality Control Director to lead the QC department in an animal health laboratory, ensuring testing and release activities meet USDA 9 CFR standards. This is an onsite, permanent role with opportunities to drive continuous improvement and cross-functional collaboration.

The role combines strategic leadership with bench work in ELISA, cell culture, and data integrity, emphasizing robust documentation and regulatory compliance.