Inspector - Quality Assurance

Overview

Under direct supervision of the Senior Quality Assurance (QA) Supervisor or QA Team Leader, this position is responsible for ensuring finished products conform to the established quality standards and agency guidelines, to ensure customer satisfaction. 

Responsibilities

• Perform disintegration test
• Perform physical tests on finished bulk
• Perform AQL Sample Inspection Defect and Defect Level Limits on finished bulk, third party bulk and outside bulk
• Perform product validation test on finished bulk when requested
• Perform FT-NIR test on TGA softgel oils
• Physically place product on QA Hold and release product when necessary
• Pull samples based on the ANSI/ASQC Z 1.4 2003 AQL requirements
• Train and use Oracle/Korber for all QA job functions
• Print Items Waiting Inspection reports and sample according to the ANSI/ASQC Z 1.4 2003 charts
• Complete all logs and product appearance check sheets
• Pull PE and PAW sheets as batch lots end
• Train to perform daily balance calibration verification
• Train to perform monthly lab equipment calibration verification
• 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
• Locate and change product status electronically
• Review PE and PAW forms when requested
• 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 that correct raw material and lot numbers are being processed
• Ensure proper recording and usage of batch records per established processes
• Accumulate all rejects and place into the appropriate containers for proper disposal or reworkprocess
• 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 andprocedures
• Actively participate in health and safety training programs and demonstrate competency based ontraining 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

Qualifications

High school diploma or equivalent•6 months direct experience in a manufacturing or quality role within manufacturing operations•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 thecGMP’s•Good documentation skills•Must be able to work flexible hours•Possess an attitude that fosters team work and promotes positive morale and respect forcoworkers of all levels within the company