JOB SUMMARY

The Quality Specialist is an essential member of the Quality Assurance team, responsible for maintaining the highest quality standards throughout the testing, release, and distribution of dietary supplements. This role requires a deep understanding and competency in 21 CFR Part 111 and 117. Key responsibilities include overseeing document control, change control, complaint management, tracking and trending adverse events and NCR/CAPA investigations to ensure compliance and product safety.

KEY RESPONSIBILITIES

• QMS System Proficiency: Demonstrates strong working knowledge of QMS platforms and related processes, including document management, complaint management, CAPAs, non-conformances, training, and quality records.
• Adverse Event Management: Supports the review, sign-off, investigation, trending, and escalation of adverse events and serious adverse events in accordance with internal procedures and regulatory expectations.
• Data Trend Analysis: Tracks, analyzes, and summarizes quality data to support risk-based decision-making, continuous improvement, and management review activities.
• Third-Party Certification Testing: Coordinates and tracks testing activities required for third-party certifications, ensuring timely completion, accurate documentation, and effective communication of results.
• Training Management: Maintains training matrices and training records to ensure employees are appropriately trained on applicable SOPs, controlled documents, forms, and GMP requirements.
• Training Facilitation: Coordinates and facilitates employee training sessions to support compliance with company policies, applicable procedures, and regulatory requirements.
• Document Control: Maintains controlled documents and ensures proposed changes are routed through the appropriate review and approval process prior to implementation.
• Change Control: Manages and monitors change control activities to ensure changes to products, processes, or documentation are appropriately assessed, approved, implemented, and documented in accordance with internal quality standards and applicable regulatory requirements.

QUALIFICATIONS

• Minimum of a bachelor’s degree from an accredited four-year college or university in a related field, or an equivalent combination of education, training, and experience that provides the required knowledge, skills, and abilities.
• 3+ years of relevant quality assurance experience in the food, dietary supplement, or related regulated industry.
• Working knowledge of dietary supplement and food quality requirements.
• Understanding of warehouse operations, manufacturing processes, and quality system requirements.
• Experience using and managing activities within Veeva QMS or a comparable quality management system.
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint, as well as Google Workspace tools.
• PCQI certification or working knowledge of Preventive Controls requirements preferred.