Quality Assurance Inspector II

Overview

Position Overview


Working under the direct supervision of the Quality Assurance (QA) Supervisor or Lead, this role ensures that finished bulk dosages meet established quality standards and comply with regulatory requirements. Shift durations 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

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

• 1 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

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.