Quality Assurance Inspector II

Specific Responsibilities

• Perform physical tests on bulk (finished bulk, finished product, or components (as necessary))
• Perform AQL Sample Inspection for Defects on finished bulk and outside bulk. Define sampling criteria based on ANSI/ASQ Z1.4 2003 AQL requirements
• Physically place product on QA Hold and release product when necessary
• Use ERP and Warehouse system for all QA job functions
• Perform daily and monthly lab equipment calibration verification activities
• Ensure that lab equipment is in proper operation and report any out of service issues
• Ensure adequate stock of supplies necessary to perform essential job duties and report when supplies are low
• Report any questionable quality or safety issues to appropriate supervisory personnel
• Change product status electronically
• Review and approve PE and PAW forms when requested
• Assists in the mentorship and training of team members
• Serve as proxy for QA Lead as needed

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 element as contained herein between the assigned start and end times for work.
• Performs such individual assignments as management may direct.
• Other duties as assigned.

Qualifications

The Candidate

Education, Experience, and Licenses

• High school diploma or equivalent
• 2-3 year direct experience in a manufacturing or quality role within manufacturing operations

Knowledge, Skills, and Abilities

• Adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) in effect assuring the quality and quantity of product produced is required
• Maintain clean work environment at all times, including and not limited to hygiene practices
• Follow batch record instructions and maintain accurate and legible production records
• Ensure proper labeling of finished product while completing all necessary paperwork / documentation as required
• Ensure proper recording and usage of batch records per established processes
• Complete all necessary paperwork and proper documentation
• Know and understand the cGMP and other regulatory compliance
• Ensure job specific safety procedures are established and followed
• Maintain awareness and enforcement of health and safety practices and activities
• Be involved in the development, implementation, and updating of health and safety plans, programs, and procedures and demonstrate competency based on training received
• Make safety a priority in daily operations by:
• Actively participating in health and safety activities,
• Ensuring compliance with regulatory requirements,
• Ensuring adequate resources are provided, and
• Providing suggestions for improvement to the health and safety program
• Assisting in other tasks as requested by the site QA Management
• Basic knowledge of MS Word and Excel, basic data entry skills
• Excellent math, verbal and written communication skills
• Ability to communicate respectfully with employees of all levels
• Must be able to handle, in an expeditious manner, multi tasks and priorities
• Make logical decision with attention to details
• Knowledge of and compliance with company policies and SOP’s and understanding of all of the cGMP’s
• Good documentation skills
• Must be able to work flexible hours
• Possess an attitude that fosters team work and promotes positive morale and respect for coworkers of all levels within the company
• Must be able to read, write, and communicate in English

Pay Rate: $19.00 per hour