Quality Assurance Department Supervisor

Position Overview

Responsible for overseeing the day-to-day operations of the Quality Assurance Department, including internal and external audits, document control, compliance, GMP training, SOP (Standard Operating Procedure) development and control, and other related programs. Identify and implement continuous improvement activities to enhance and sustain GMP compliance in the production of dietary supplements and related products.

Responsibilities

• Enforce GMP compliance throughout the organization and with strategic partners.
• Review and assist in developing quality system policies and procedures.
• Maintain and implement quality system policies and procedures.
• Develop, update, and maintain standard operating procedures (SOPs).
• Participate in and/or lead external audits and coordinate with functional groups on the development of corrective and preventive action (CAPA) responses.
• Prepare audit reports and monitor the sustainability and effectiveness of identified CAPAs.
• Prepare quality reports and conduct monthly meetings with the Operations group to discuss quality issues and improvement opportunities.
• Oversee the GMP program and collaborate with all functional departments to ensure its effectiveness.
• Perform additional tasks or special projects as assigned by senior Quality Management.
• Perform other duties as assigned.

Education, Experience, and Licenses

• Bachelor’s Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology, Biology, or a related field; equivalent job experience may be considered.
• 2–5 years of relevant experience preferred.
• Professional quality certifications such as CQE, CQA, PCQI, etc., are desired.
• Minimum 5–10 years of experience establishing and maintaining quality systems in the dietary supplements and/or pharmaceutical manufacturing industry, with 3+ years in a supervisory role.

Knowledge, Skills, and Abilities

• Computer literate and familiar with commercial software such as Microsoft Office, including Word, Excel, Access, and PowerPoint.
• Knowledge of 21 CFR 110 and 111 quality regulations and current Good Manufacturing Practices (cGMP) guidelines.
• Ability to work in a manufacturing environment with airborne powder, noise, and moving equipment.
• Able to communicate, write, and understand English.
• Ability to sit,