Manager, Quality Assurance

Position Overview

Responsible for overseeing the day-to-day operations of the Quality Assurance Department including internal and external audit, document control, compliance, GMP training, SOP (standard operating procedures) development and control, and other related programs and identify continuous improvement activities to enhance and sustain GMP compliance in the production of Dietary Supplements and other IVC (International Vitamin Corporation) products.

Specific Responsibilities

• Enforce GMP compliance in the organization and other strategic partners
• Review and assist in developing the quality system policies and procedures
• Maintain and implement the company's quality system policies and procedures
• Develop, update, and maintain the company's standard operating procedures (SOP's)
• Participate and or lead external audits and coordinate functional groups with the development of their corrective and preventive action (CAPA) responses, prepare audit reports and monitor sustainability of identified CAPA's
• Prepares quality reports and conducts monthly meetings with the operations group to discuss quality issues and improvements
• Oversee the GMP squad and collaborate with all functional departments to ensure effectiveness of the program
• Perform additional tasks or special projects as assigned senior Quality Management

General Responsibilities

• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation
• Requires regular attendance to perform essential elements as contained herein between the assigned start and end times for work
• Performs such individual assignments as management may direct
• Other duties as assigned

Education, Experience, and Licenses

• Bachelor's Degree in a Scientific or Engineering discipline, with exposure to Chemistry, Microbiology, and/or Biology, in a related field, or equivalent job experience
• 2-5 years of experience
• Professional quality discipline certifications (CQE, CQA, PCQI, etc.) 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 Word, Excel, Access and PowerPoint
• Knowledge of 21 CFR 110 and 111 quality regulations and current Good Manufacturing Practices (cGMP) guidelines
• Capability to work in a manufacturing environment with air-borne powder, noise, and moving equipment
• Able to communicate, write and understand English
• Ability to sit, walk, stand, and reach frequently