Quality Assurance Associate

1 week ago

Sugar Land, United States Himalaya Wellness Company Full time

Summary:

The Quality Assurance Associate reports directly to the VP of Botanical Science and Quality and is

responsible for implementing, enhancing and overseeing the company's quality management system (QMS) requirements. The Quality Assurance Associate ensures the manufacture and distribution of dietary supplements comply with all applicable regulations, including Title 21 CFR Part 111. The Quality Assurance Associate will assist in the planning, coordination, and execution of product testing to determine if specifications have been met, investigate quality issues, and provide training to the broader team.


Key Responsibilities:

• Interpret, build upon, and follow company quality management system (QMS) requirements and ensure that processes are consistent with Food and Drug Administration (FDA) Current Good Manufacnituring Practices (cGMPs) under the guidance of the VP of Botanical Science and Quality.

• Help develop and improve QMS processes for US domestic 3PL production and help create

specifications for implementation across all product lines in collaboration with the VP of Botanical

Science and Quality.

• Create, maintain, and follow standard operating procedures (SOPs) for all QMS activities to ensure consistency and compliance.

• Document QMS activities with internal reporting and audits.

• Assist in the planning, execution, and management of product inspection and testing for quality and conformance to specifications and deliverables.

• Review all incoming shipments to ensure that the required paperwork, including Master

Manufacturing Records (MMRs), Batch Production Records (BPRs), and supplier and laboratory

Certificates of Analysis (COAs) are present and properly completed.

• Maintain exact records of all incoming shipment reviews and any issues or discrepancies identified.

• Maintain complaint and nonconformance processing through records and tracking systems, including root-cause analysis and corrective actions.

• Identify training needs with shipping personnel and ensure companywide compliance.

• Provide training and support to shipping team and 3PL members that covers systems, policies,

procedures, and core processes.

• Investigate reports of product quality issues and ensure resolution per company guidelines and

regulatory requirements.

• Develop or update procedures for capture, investigation, and documentation of product complaints online and through incoming CS reports.

• Monitor risk-management procedures, keep problem logs, and report issues to the VP of Botanical Science and Quality, as well as other managers and product developers.

• Assist with preparing for and participating in FDA (Food and Drug Administration) and GMP (Good Manufacturing Practices) audits, including providing documentation and answering any quality related questions.

• Along with VP of Botanical Science and Quality and VP of Supply Chain and Operations, conduct onsite audits of third-party manufacturing facilities to assess cGMP compliance both domestically and abroad.


Qualifications and Requirements:

• Bachelor's degree in a relevant field, such as quality assurance, regulatory affairs, or a natural

sciences discipline.

• Minimum 3-5 years of experience in a quality assurance or regulatory compliance role, preferably in the dietary supplement or pharmaceutical industry.

• Thorough understanding of Title 21 CFR Part 111 and other relevant regulations governing the

manufacture and distribution of dietary supplements.

• Ability to read and interpret MMRs, BPRs, and COAs.

• Strong analytical, problem-solving, and decision-making skills.

• Strong attention to detail and organization skills.

• Excellent written and verbal communication skills

• Experience creating and following standard operating procedures (SOPs) for quality assurance

activities.

• Willingness to travel to third-party manufacturing facilities as needed.

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