Quality Assurance Inspector II

About the role

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

• 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.
• Assist in the mentorship and training of team members.
• Serve as proxy for QA Lead as needed.
• Adhere to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs).
• Maintain a clean work environment, including 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.
• Ensure proper recording and usage of batch records per established processes.
• Complete all necessary paperwork and proper documentation.
• Know and understand cGMP and other regulatory compliance.
• Ensure job-specific safety procedures are established and followed.
• Maintain awareness and enforcement of health and safety practices.
• Be involved in the development, implementation, and updating of health and safety plans, programs, and procedures.
• Make safety a priority in daily operations by actively participating in health and safety activities, ensuring compliance with regulatory requirements, and providing suggestions for improvement.
• Perform other duties as assigned by site QA Management.

Requirements

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

Skills

• 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.
• Ability to handle multiple tasks and priorities in an expeditious manner.
• Logical decision-making with attention to detail.
• Knowledge of and compliance with company policies, SOPs, and cGMPs.
• Good documentation skills.
• Ability to work flexible hours.
• Attitude that fosters teamwork and promotes positive morale.
• Must be able to read, write, and communicate in English.