Quality Administrative Assistant

Position Summary

The Quality Administrative Assistant will be responsible for the maintenance of documentation within Quality, as well as overseeing several support systems. Will work cross-functionally with Quality, Purchasing, and G&A to ensure that files are being processed correctly and in a timely manner. Must be detail-oriented.

Responsible for the day-to-day scanning, filing, and retention of Compounding and Packaging records, and initiation and completion of Quality purchase orders for supplies and equipment. This role ensures accurate document control, training records, and quality data management in a GMP-regulated environment.

The ideal candidate will demonstrate strong attention to detail, situational awareness, and the ability to ensure that internal customers are being given all needed information and feedback for task completion.

Responsibilities and Essential Duties

• Ensure SOPs are followed to meet and exceed Quality standards set forth in specifications.
• Ensure team maintains highest levels of safety to build an environment where the team’s well-being is a top priority.
• Scan and file completed Compounding and Packaging documentation and maintain retention schedules.
• Support document lifecycle activities such as archival and retrieval in accordance with document control procedures.
• Ensure compliance with Good Documentation Practices (GDP) across all quality records.
• Support onboarding activities related to quality training and documentation requirements through eQMS (ETQ).
• Creation, collection, issuance, and retention of Logbooks throughout facility.
• Initiate, maintain, and complete Quality purchase orders per internal processes and in a timely manner.
• Generate GMP compliant records as required by SOPs, methods, or regulations.
• Support the company mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
• Own and lead special projects as assigned.
• Perform all other assigned duties as required by Quality Management.

Technical Skills Required

• Detail-oriented.
• Good verbal and written communication and basic computer literacy (MS Office) required.
• Good math proficiency.
• Organized and analytical.
• Electronic Quality Management Systems (eQMS), preferably ETQ.

Experience Required

• High School diploma or equivalent; Associate degree preferred.
• 1-3 years of administrative or coordinator experience in a Quality, Manufacturing, Regulatory, or other controlled environment.Prior experience supporting Quality Assurance and/or Quality Control functions preferred.
• Exposure to eQMS such as ETQ, TrackWise, MasterControl, or similar preferred.
• Proven ability to manage multiple tasks, deadlines, and priorities in a structured environment.

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
• Physically able to lift 50 pounds periodically.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
• Prolonged use of computer screen.
• Exposure to repetitive motions (making substantial movements/motions of the wrists, hands, and/or fingers).