Quality Assurance Inspector II

International Vitamin Corporation•Anderson, SC

25d•Onsite

About The Position

This role ensures that finished bulk dosages meet established quality standards and comply with regulatory requirements, working under the direct supervision of the Quality Assurance (QA) Supervisor or Lead. The shift is Monday-Thursday from 7:00 am to 5:00 pm, with a pay rate of $19.00 per hour.

Requirements

High school diploma or equivalent
1 year direct experience in a manufacturing or quality role within manufacturing operations
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

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.
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.