Description Overview
The Quality Assurance Manager ensures that all infant formula products are produced, tested, stored, and released in full compliance with FDA regulations and company standards, leading daily QA operations and partnering with Manufacturing, Laboratory, Engineering, and Warehouse teams.
Scope of the Role
- Oversee QA activities for infant formula production, including batch record review, product release, and quality system oversight.
- Ensure compliance with 21 CFR 106/107 and cGMP requirements.
- Lead investigations, root-cause analysis, and CAPA for deviations and quality events.
- Conduct internal audits and support FDA, customer, and corporate audits.
- Review and approve SOPs, change controls, validation documents, and quality-critical records.
- Collaborate with cross-functional teams to resolve issues and improve product and process performance.
- Monitor quality metrics and drive continuous improvement initiatives.
- Train, mentor, and lead QA staff to support a strong quality culture.
- Serve as a key decision-maker for product quality and release.
Experience Required
- Bachelorβs degree in a scientific or technical field.
- Five yearsβ experience in a regulated manufacturing environment (infant formula, food, or pharma preferred).
- Prior leadership or supervisory experience in QA.
- Strong understanding of cGMP, FDA regulations, and quality systems.
- Excellent communication, problem-solving, and decision-making skills.
Benefits
- Competitive compensation, benefits for you and your family, and career development opportunities.
Application Instructions
- Click the APPLY button at the bottom of the application (SAVE only saves your profile; it does not submit).