Quality Assurance Manager - Dietary Supplement Manufacturing American Pharma MFG, Inc.

Location:

Ontario, CA 91761

Job Type:

Full-Time |

On-Site Schedule:

Monday -

Friday Pay:

Starting $85-105k (based on experience) Job Description American Pharma MFG, Inc. is seeking an experienced, detail-oriented, and highly motivated Quality Assurance Manager to oversee our Quality Assurance and Quality Control operations at our dietary supplement manufacturing facility in Ontario, California. We are a full-service dietary supplement manufacturer specializing in capsule manufacturing, powder blending, encapsulation, bottling, labeling, packaging, and contract manufacturing. The ideal candidate will have a strong background in FDA regulations, 21 CFR Part 111, Current Good Manufacturing Practices (cGMP), quality management systems, and dietary supplement manufacturing. This is a hands-on management position requiring an individual who can oversee daily quality operations, maintain regulatory compliance, lead audits, implement corrective actions, and work directly with production management to ensure our products meet established quality and safety standards. We are looking for someone who is proactive, organized, knowledgeable, and capable of taking ownership of our facility's Quality Management System. Key ResponsibilitiesQuality Assurance & Regulatory Compliance Oversee and manage the facility's Quality Assurance and Quality Control programs. Ensure compliance with FDA regulations, including 21 CFR Part 111, applicable cGMP requirements, and company quality standards. Establish, maintain, review, and improve Standard Operating Procedures (SOPs). Ensure all manufacturing, packaging, labeling, and holding operations follow approved procedures. Monitor facility compliance through routine inspections, internal audits, and production floor walkthroughs. Ensure appropriate quality control review and approval of manufacturing documentation and material disposition decisions. Maintain facility readiness for FDA inspections, third-party certification audits, and customer audits. Manufacturing & Production Quality Oversight Oversee quality compliance throughout all production departments, including: Raw material receiving and inspection Weighing and dispensing Powder blending and mixing Capsule encapsulation Capsule polishing and metal detection Bottling and packaging Labeling and finished product inspection Review and approve Master Manufacturing Records (MMRs) and Batch Production Records (BPRs). Verify proper equipment cleaning, sanitation, calibration, and maintenance documentation. Ensure production personnel follow established procedures for material identification, traceability, and prevention of cross-contamination. Oversee in-process quality inspections and finished product evaluations. Manage quality holds, product deviations, nonconforming materials, and batch release procedures. Documentation & Quality Management Systems Maintain accurate, organized, and audit-ready quality documentation. Develop, implement, and maintain corrective and preventive action (CAPA) programs. Investigate manufacturing deviations, quality complaints, and nonconformances. Conduct root cause analyses and verify the effectiveness of corrective actions. Maintain change control records, training records, quality logs, and inspection documentation. Oversee document control, including SOP revisions, controlled forms, and record retention. Ensure proper completion and review of production and quality records. FDA Inspections & Third-Party Audits Serve as a primary quality contact during FDA inspections, customer audits, and certification audits. Prepare and maintain documentation required for regulatory inspections. Coordinate responses to inspection observations and audit findings. Develop and implement corrective action plans to address identified deficiencies. Conduct internal audits to identify compliance risks and improvement opportunities. Support compliance with applicable

NSF/ANSI

455-2 and organic certification requirements. Work with senior management to continuously strengthen the facility's regulatory compliance and quality systems. Laboratory Testing & Quality Control Coordinate raw material, in-process, and finished product testing with qualified third-party laboratories. Review Certificates of Analysis (COAs), raw material specifications, and finished product specifications. Ensure appropriate identity, purity, strength, composition, and contaminant testing or examinations are conducted as required. Coordinate microbiological, heavy metal, and other required quality testing. Maintain testing records and ensure results meet established specifications. Investigate out-of-specification (OOS) results and implement appropriate corrective actions. Oversee supplier qualification and raw material approval processes. Employee Training & Quality Leadership Train production and quality personnel on cGMP requirements, SOPs, hygiene, documentation, and quality procedures. Conduct routine GMP training and refresher sessions. Work closely with the Operations Manager, VP of Operations, and production supervisors. Identify quality-related training needs and areas requiring improvement. Promote accountability, consistency, and a strong quality culture throughout the facility. Ensure employees understand and follow established quality and safety procedures. Required Qualifications Minimum 3-5 years of Quality Assurance or Quality Control experience in dietary supplement, nutraceutical, pharmaceutical, or related FDA-regulated manufacturing. Previous supervisory or quality management experience preferred. Strong working knowledge of

FDA 21 CFR

Part 111 and cGMP regulations. Experience preparing for and participating in FDA inspections and customer audits. Experience developing and maintaining SOPs, CAPAs, and quality documentation. Knowledge of batch record review, manufacturing documentation, and product release procedures. Familiarity with raw material specifications, COAs, and laboratory testing requirements. Strong organizational, analytical, problem-solving, and communication skills. Ability to work independently, prioritize responsibilities, and manage multiple quality projects. Proficiency in Microsoft Office, including Word and Excel. Must be comfortable working directly on the manufacturing floor and interacting with production personnel. Preferred Qualifications Bachelor's degree in Chemistry, Biology, Food Science, Pharmaceutical Sciences, or a related field. Experience specifically in dietary supplement contract manufacturing. Knowledge of

NSF/ANSI 455-2

certification requirements. Experience with USDA Organic certification and quality documentation. Experience implementing or improving a Quality Management System (QMS). Familiarity with environmental monitoring, sanitation programs, metal detection verification, and equipment qualification. Experience leading regulatory remediation, CAPA implementation, and quality system improvements. Bilingual English/Spanish is a plus. What We're Looking For We are seeking a Quality Assurance Manager who is not only knowledgeable about regulations but also capable of implementing and enforcing them in a fast-paced manufacturing environment. The successful candidate must be willing to take a hands-on approach to quality management, identify potential compliance issues before they become problems, and work collaboratively with our production and management teams. This position requires someone who can confidently manage audits, maintain regulatory compliance, enforce GMP standards, and help build a stronger, more efficient quality system. Work Schedule & Location Monday -

Friday Full-Time, On-Site Position Location:

Ontario, California This is an on-site position requiring regular presence at our manufacturing facility. Remote work is not available. How to Apply Interested candidates should submit their resume through Indeed, highlighting their experience in quality management, FDA-regulated manufacturing, GMP compliance, and regulatory audits. American Pharma MFG, Inc. is an Equal Opportunity Employer. We look forward to welcoming an experienced quality professional to our team.

Pay:

$86,200.00 - $104,000.00 per year

Work Location:

In person