Quality Assurance Specialist (Tues-Fri 5:00pm to 3:30am)

Summary:

The Quality Assurance Specialist is responsible for advancing overall quality and enhancing efficiencies in all aspects of an ISP and FDA registered Distribution Center operation.

Job Duties:  -

•  Maintains the Quality Management Systems to include: documentation, training and auditing and ensuring adherence to ISO compliance, all SOPs and Work Instructions.
• Creates, evaluates, improves and enforces techniques for increasing both quality and safety efficiency and effectiveness to meet company and customer requirements
• Daily communicates and coordinates with customers to handle all quality issues, holds, releases, special projects/requests, information requests, cross-functional projects, and reporting during peak events
• Audits and enforces compliance with GMP standards and ensures all work is documented thoroughly
• Supplies projections to account management as needed when special projects arise
• Assists management with quality-related special requests and/or projects
• Provides instruction to employees as needed to meet the needs of inspection projects
• Ensures the proper and safe use of all equipment included PIT and packaging equipment
• Identifies gaps in training and coordinates with Supervisors for effective training processes
• 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
• Minimum of 2 years of Experience with Synapse include Wave Planning, Front end Labeling, Item Master Maintenance and pick font maintenance.
• Knowledge of FDA, CGMP, and ISO Quality Management System
• PC literate with experience with Microsoft Outlook, Word 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. The 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”.