Quality Assurance Technician - US

Kindeva•Brentwood, MO

6d•Onsite

About The Position

The Quality Assurance Technician provides quality oversight of operations—including equipment and material preparation, compounding, filling, inspection, and packaging—in aseptic and controlled environments. The role ensures activities conform to established specifications, procedures, cGMPs, and regulations. The technician performs readiness walk-throughs, line clearances, in-process checks, and verifications, and works with cross-functional teams to support manufacturing, continuous improvement, investigations, and changes. The position reviews manufacturing documentation and supports manufacturing and testing activities through shop-floor oversight, investigations, change management, SOP revisions, and batch documentation review. It also involves data collection and reporting, participation in audits, support for training Quality Assurance colleagues, and ERP transactions as applicable. The role requires onsite attendance and the ability to work in a Grade A/B classified area after completing aseptic gowning qualification. Overtime and weekend work may be needed to support business initiatives.

Requirements

High school diploma or GED.
Strong attention to detail and organizational skills.
Ability to follow instructions and procedures.
Basic knowledge of cGMPs, including USFDA, Health Canada, PIC/S, and/or EudraLex requirements.
Demonstrated decision-making ability emphasizing overall quality, site priorities, results, and achievements.
Ability to work well within own and interdepartmental teams.
Ability to work under short timelines while maintaining quality work.
Effective written and oral communication skills.
Willingness to work overtime and weekends as needed to support business initiatives.
Ability to complete aseptic gowning qualification and work in a Grade A/B classified area.
Ability to sit, stand, and occasionally lift items up to approximately 25 pounds.
Ability to meet vision requirements: near vision score of 8 or better with both eyes using a Titmus II tester, or 20/25 on a near-point Snellen acuity card at 16 inches; normal color vision confirmed by Ishihara screening.
Ability to attend work onsite; the position cannot be performed remotely or by telecommuting.
Ability to multitask across capabilities and functions, manage competing priorities, and respond to communications and meetings that may not be limited to core hours or onsite presence.

Nice To Haves

Bachelor's degree in a scientific field and industry experience are preferred.

Responsibilities

Review manufacturing-related documentation to ensure adherence to processes and compliance with approved SOPs and cGMPs.
Perform inspection-readiness walk-throughs, line clearances, and in-process checks in support of manufacturing activities.
Provide QA support for manufacturing and testing activities, including shop-floor oversight, deviation and laboratory investigations, change management, SOP revisions, and batch documentation review.
Proactively identify and address non-conformances in manufacturing operations.
Work independently and collaboratively with own and interdepartmental teams, with minimal guidance and under short timelines while maintaining quality work.
Collect and report departmental data, and take responsibility for that data.
Promptly alert management to issues identified during batch production or record reviews that may adversely affect manufactured products.
Review SOPs, forms, logbooks, and Master Batch Records for accuracy and compliance with established procedures.
Participate in internal GMP audits and support customer and regulatory audits.
Assist in training Quality Assurance colleagues.
Understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
Perform ERP transactions, as applicable.
Complete other tasks assigned by management.