Quality Assurance Specialist

Job Overview

We are seeking a detail-oriented and scientifically grounded Quality Assurance Specialist to support regulatory compliance and quality operations for VIVA Manufacturing. This is an onsite position requiring a self-starter with strong knowledge of 21 CFR Part 111 cGMP requirements and practical experience working in or alongside FDA-regulated manufacturing environments.

The QA Specialist executes day-to-day quality assurance activities that support the department's SOP compliance, deviation/CAPA, complaint investigation, and audit-readiness functions under 21 CFR Part 111. The role documents, escalates, and follows through on quality issues identified, under the direction of the QA and Regulatory Affairs Manager.

Key Responsibilities

• Generate changes to relevant documentation, processes, or components.
• Support execution and documentation of deviation, out-of-specification, and CAPA investigations.
• Implement corrective actions when documented procedures are not followed.
• Build and maintain internal policies and procedures designed to produce safe, pure, and quality dietary supplement products.
• Retain quality assurance records in accordance with applicable record retention policies.
• Review documentation supporting the qualifications of any supplier.
• Assist in investigating and documenting product complaints; escalate validated complaints to the QA Manager/Director for review, disposition, and closure. Perform training on Quality Unit procedures for appropriate personnel.
• Conduct routine SOP-adherence checks on the production floor and document findings for the QA Manager.
• Support the internal audit program — scheduling, conducting, and documenting internal audits, and tracking corrective actions to closure.
• Support FDA inspection-readiness activities, including mock inspections and document retrieval drills.
• Perform training on Quality Unit procedures for appropriate personnel.
• Promptly escalate SOP non-adherence and quality risks observed on the floor to the QA Manager or QA Director — this role is a primary set of eyes for the culture change the department is driving.

Required Qualifications

• Bachelor’s degree or higher in Biology, Microbiology, Chemistry, Food Science, Pharmaceutical Sciences, or a related scientific discipline.
• > 3 years of hands-on quality assurance experience in the dietary supplement industry.
• Working knowledge of 21 CFR Part 111 (Current Good Manufacturing Practice for Dietary Supplements).
• Proficiency in reviewing and approving QA documentation including SOPs, batch records, COAs, and deviation reports.
• Strong written and verbal communication skills; ability to work effectively in a fully remote environment.
• High attention to detail and ability to manage multiple priorities independently.
• Preferred Qualifications
• Experience with OTC drug, cosmetic, or food product regulatory frameworks (21 CFR Part 110, 210/211).
• Familiarity with NSF, USP, or other third-party certification standards for dietary supplements.
• Experience using quality management systems (QMS) software.
• HACCP, SQF, or ASQ Certified Quality Auditor (CQA) certification is a plus.

Pay: $24.00 - $26.00 per hour

Expected hours: 40.0 per week

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $24 - $26