What are the responsibilities and job description for the Quality Assurance and Sanitation Manager position at APEXcm, Inc. (APEX)?
Company Description
The Quality Assurance and Sanitation Manager is responsible for overseeing the company’s Quality Assurance program and ensuring site-wide compliance with applicable regulatory, customer, and certification standards including 21 CFR Part 111, NSF/ANSI 455-2, and GMP guidelines. In addition, this role manages the implementation, auditing, and continuous improvement of the sanitation program. This is a leadership position that oversees a team of 3 to 7 employees, fostering an environment of accountability, quality, and operational integrity. While responsible for sanitation oversight, the role does not include the execution of routine sanitation tasks.
Role Description
1. Quality Assurance Program Management
a. Lead the development, implementation, and maintenance of the facility’s Quality
Management System (QMS).
b. Ensure compliance with 21 CFR Part 111, Part 117, FSMA, NSF/ANSI 455-2, and other applicable regulatory standards.
c. Review batch production records, Certificates of Analysis (COAs), and finished product documentation.
d. Oversee nonconformance management, deviation tracking, CAPA execution, and internal audit readiness.
e. Manage document control systems, change control processes, and complaint handling procedures.
f. Support third-party audits and customer inspections, ensuring corrective actions are tracked and resolved.
g. Serve as the primary point of contact for QA-related customer documentation and certifications.
h. Conduct vendor qualifications by coordinating with the purchasing department and external vendors to gather information.
i. Conduct label review before printing in coordination with the label control department and R&D.
j. Other duties as assigned.
2. Sanitation Program Oversight
a. Implement and maintain the facility's Sanitation Standard Operating Procedures (SSOPs) in alignment with regulatory and certification requirements.
b. Conduct routine audits and inspections of sanitation logs, filter cleaning schedules, and daily cleaning reports to ensure compliance.
c. Collaborate with various department leads to coordinate their sanitation responsibilities and 3rd party cleaning services to ensure work is completed as scheduled and documented accurately.
d. Maintain sanitation records for internal and third-party audits.
e. Regularly review and update the sanitation program based on audit findings, regulatory updates, or facility needs.
3. Leadership & Team Management
a. Supervise a team of 3–7 quality assurance and sanitation personnel, providing mentorship, task delegation, and performance evaluation.
b. Develop and lead GMP and sanitation training initiatives for new hires and existing staff.
c. Foster a culture of continuous improvement and accountability within the QA department.
d. Facilitate cross-functional communication between QA, Operations, Sanitation, and external partners.
Qualifications
Education: Bachelor’s degree in Food Science, Biology, Chemistry, or related field preferred.
Experience:
1. 3–5 years in a QA leadership role within a regulated manufacturing environment (dietary supplements, food, beverage, pharma, or cosmetics).
2. Strong understanding of sanitation and environmental monitoring programs.
3. Hands-on experience with GMPs, 21 CFR 111, NSF/ANSI 455-2, HACCP, and FSMA.
Knowledge, Skills and Abilities:
1. Excellent leadership and interpersonal skills.
2. Proficient in Microsoft Office and QMS software.
3. Strong documentation, organization, and time-management abilities.
4. Bilingual (English/Spanish) preferred but not required.