OVERALL, PURPOSE/FUNCTION: Ensure the overall quality of manufactured products through the execution of established processes. Delegate assignments and tasks to QA Technicians as needed. Ensure all scheduling requirements are met.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following.

• Supervise and direct quality assurance technicians who are responsible for enforcing Good Manufacturing Practices and other quality-related policies ensuring product meets quality standards.

• Identify, solve, and prevent problems affecting quality that do not comply with requirements.
• Supervise and direct quality assurance technicians who are responsible for enforcing Good Manufacturing Practices and other quality-related policies ensuring product meets quality standards.
• Identify, solve, and prevent problems affecting quality that do not comply with requirements.
• Responsible for overseeing day-to-day operations, disciplinary actions, job assignments and procedures are performed in a timely manner.
• Implementation of all GMP guidelines, including safety and Personal Protective Equipment (PPE), are being followed.
• Ensure good performance by quality assurance technicians by mentoring, training, setting expectations, providing accountability, and performing evaluations.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and housekeeping.
• Reviews quality assurance instructions, specifications, and production schedules to determine method of conducting inspections and tests, sequence of operations, and work assignments.
• Cross functional capabilities of all job task in the Quality department in lieu of absences.
• Evaluate raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
• Assist in the coordination of testing results involving finished products, raw materials, and packaging components to collect data, to determine the appropriate release, holds or destruction associated with these materials.
• Assist in the implementation of policies, operating procedures, quality systems, training and programs which ensure proper testing, evaluation, inspection, and technical support to meet quality standards.
• Assess a product and identify any issues before it is sent to the customer. When issues are found, quality supervisors use root cause analysis and corrective action planning.
• Schedule, attend and participate daily, weekly, and monthly meetings to set priorities, address issues and problems.
• Research and collaborate with respective departments to achieve immediate corrective/preventative action response to pertinent customer and internal CAPA's, as required.
• Participate in all internal and customer audits/inspections that could result in corrective action responses.
• Identify areas for improvement and present solutions to the Quality Assurance Department Management to improve work efficiency.
• Communicate knowledge, skills, and information with all necessary personnel.
• Maintain a fair and professional work environment that focuses the business objectives, but also balances quality of work-life factors for employees.
• Perform other duties as directed/assigned by the Quality Assurance Department management.
• Exercise good judgment and respond positively to instructions and follow standard policies and procedures

QUALIFICATIONS/REQUIREMENTS

Education and/or Experience

• Some college/technical school preferred
• Equivalent work experience
• GED/High School Diploma

Professional Designations / Licensures / Certifications

• None required

Skills, Knowledge, and Abilities

• Communication Skills: written and verbal
• Ability to multi-task
• Leadership Skills
• Planning and organizing
• Attention to detail
• Problem analysis and problem solving
• Data collection, management, and analysis
• Moderate knowledge of Microsoft Office

Work Environment / Physical Demands

• Fast-paced work enviroment
• Work requires standing for multiple hours.

• Lifting required to 50lbs.