Inspector, Quality Assurance

Overview

Under direct supervision of the 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. Shift lengths may vary from 8,10, or 12 hours depending on assigned area. Weekend shift schedules require two 8 hour days and two 12 hour days.

Responsibilities

 

Perform disintegration test• Perform physical tests on finished bulk• Perform AQL Sample Inspection Defect and Defect Level Limits on finished bulk• Physically place product on QA Hold and release product when necessary• Perform in process packaging line inspections to include all Bottle packaging and Specialtypackaging operations based on customer requirements• Train to perform weekly verification of Packaging Detection Systems to include metal detection,label vision, seal detector, x-ray and line clearance.• Pull samples based on the ANSI/ASQC Z 1.4 2003 AQL requirements• Train and use Oracle and/or iWMS system for all QA job functions• Print Inspection and specification sheets and sample according to the ANSI/ASQC Z 1.4 2003charts• Maintain the comparison samples in QA and Packaging• Assists with review of In-House and Contracted finished goods GMP documentation (includingManufacturing and/or Packaging Batch Records and other documentation) to ensure compliance• Perform final Use and Disposition of finished bulk and finished packaging goods in Oracle• Issue labels to work orders and return all unused labels to electronic stock after verification oflabel count through the label rewind machine• Complete all logs and product specification check sheets• Train to perform daily balance 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 whensupplies are low• Report any questionable quality or safety issues to appropriate supervisory personnel• Locate and change product status electronically

Assist in delivering retains to the retain area.• Flexible to assist in other duties as requested/assigned

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 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 forcoworkers of all levels within the company