GMP/FDA Warehouse QA Lead

Quality Assurance Supervisor Shift: Monday-Friday 8am to 4pm Summary: The Quality Assurance Supervisor is responsible for advancing overall quality and enhancing efficiencies in all aspects of an ISP and FDA registered Distribution Center operation. Job Duties :

• Monitors daily quality, and overall effectiveness of processes throughout the operation
• Maintains the Quality Management Systems to include: documentation, training and auditing
• Creates, evaluates, and improves processes for increasing both efficiency and effectiveness
• Communicates with customers daily to handle all quality issues, holds, releases, special projects and special requests
• Coordinates with customers to address quality issues in all aspects of the operation
• Ensures that all work is conducted according to GMP standards and all work is documented thoroughly
• Conducts weekly process audits and paperwork audits throughout the operation
• Supplies projections and billing to account management as needed when special projects arise
• Communicates and assists with all quality related issues, special requests, and projects to other account facilities
• Maintains all documents including all SOPs and Work Instructions for all account facilities.
• Manages team when inspections are performed as well as VAS staff to conduct projects serving the account
• Orders and manages temporary employees as needed to meet the needs of inspection projects
• Schedules labor and plans inspection projects
• Ensures the proper and safe use of all equipment included PIT and packaging equipment
• Assists in handling of damage, spoilage, reporting, and destruction orders
• Maintains safe and organized work environments
• Verifies and retains all training of all employees in 1620
• Identifies gaps in training and coordinates with Supervisors for effective training processes
• Implements performance evaluations
• Monitors and reports on all pest control devices communicating with pest control company as needed
• Other duties as required and assigned

Requirements:

• High school diploma or GED (General Education Diploma) equivalency
• Bachelor’s degree from a 4 year college or university preferred
• Minimum 3 to 5 years related experience and/or training; or an equivalent combination of education and experience
• Knowledge of FDA, CGMP, and ISO Quality Management System
• PC literate with experience with Microsoft Outlook, Word, Viso and Excel
• Ability to apply common sense understanding to carry out instructions
• Ability to write reports, business correspondence and procedure manuals required
• Must also be able to effectively present information and respond to questions from customers
• Ability to define problems, collect data, establish facts and draw valid conclusions

Environment: While performing the duties of this job, the employee is regularly required to stand, walk, use hands to finger, handle, or feel, reach with hands and arms; stoop, kneel, or crouch. The employee is occasionally required to sit and climb or balance. The incumbent must regularly lift and/or move up to 50 pounds. T he employee is occasionally exposed to moving mechanical parts and vehicles and can be exposed to extreme heat and extreme cold including climates consistent with outside weather conditions. The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Job Duties as documented in this job description are considered “Essential Functions” and have been created by the standards of the Equal Employment Opportunity Commission (EEOC). The standards of the Americans with Disabilities Act (1990) require that employees be able to perform “Essential Functions” of the job with or without reasonable accommodation. Reasonable accommodations may be made to enable individuals with disabilities to perform the “Essential Functions”. #J-18808-Ljbffr GEODIS