Quality Assurance Specialist

• Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site.
• Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager.
• Provide cGMP and controlled document training for new hires and refresher training annually for all warehouse departments and maintain training records.
• Assist employees in submitting Quality Assurance policies and cGMP procedures.
• Assist departments with coordinating audit information and recommend appropriate data-gathering mechanisms, procedures, etc.
• Is familiar with cGMP standards and/or ISO certification in the same or related industry.
• Document control expert for revision control, processing, and filing (hard copy and electronic).
• Maintain Excel tracking logs and create matrix and reports to assist the Compliance Manager in evaluating trends.
• Work with the Returns team on any customer complaint returns or undeliverable packages.
• Perform daily and monthly DC audits/inspections and ensure any corrective actions from audits are closed.
• Responsible for knowing current QA regulations pertinent to the dietary supplement industry and training and enforcing regulations within the distribution center.
• Perform internal audits at the distribution center as required and ensure preparedness for regulatory on-site audits.
• Assist the Senior Manager of Quality with managing quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
• Maintain current and accurate records of all relevant communications, audits, corrective action plans, preventative maintenance, and effectiveness monitoring.
• Perform other assigned duties as necessary within the realm of the Quality department.
• Work independently in an on-site (not a hybrid/remote) role.

Requirements:

• Detail-oriented, organizational, and investigative qualities essential
• Focused and self-starter mentality.
• Excellent verbal and written communication skills
• Interpersonal skills for successful interaction with company employees at all levels and possibly regulatory authorities
• Expertise in using Microsoft programs (Word, Excel, PowerPoint).
• Familiar with cGMP standards and/or ISO certification in the same or related industry.
• Experience with an Inventory ERP system is a plus.
• Associate degree required; Bachelor's degree preferred.
• 2-3 plus years of related quality coordination experience in the same or related regulated industry.
• Ability to work independently within the warehouse environment.
• Comfortable dealing with upper management, auditors, etc.