Quality Assurance Technician (3rd Shift)

Kindeva•Maryland Heights, MO

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make QA Technician provides Quality oversight of Operations (equipment and material preparation, compounding, filling, inspection, and packaging activities) in both aseptic and controlled environments to ensure conformance to established specifications, procedures, cGMPs and regulations. The QA Technician performs readiness walk-throughs, line clearance, in-process checks and verifications in support of manufacturing activities and engages with cross functional teams as needed to support continuous improvement activities, incident investigations and changes. Role Responsibilities Reviews manufacturing related documentation to ensure processes adhereance and compliance with approved SOP’s and cGMPs. Responsible for performing inspection readiness walk-throughs, line clearance and in-process checks in support of manufacturing activities Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation reviewProactively identify and address non-conformances in manufacturing operations Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work. Collects, reports and is responsible for departmental data. Alerts management promptly to any issues identified during batch production / record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards. Reviews SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures. Participates in internal GMP audits and supports customer and regulatory audits. Assists in training Quality Assurance colleagues. Has the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas. Performs ERP transactions, as applicable. Must be willing to work overtime and weekends as needed to support business initiatives. Other tasks assigned by management.

Requirements

HS/GED.
The individual must have strong attention to detail and organizational skills.
The individual must be able to follow instructions and procedures
Basic knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
Demonstrated decision making ability with emphasis on overall quality, site priorities, results and achievements.
Works well in a team environment within own team and interdepartmental teams.
Must work under short timelines while maintaining quality work.
Must have effective written and oral communication skills.

Nice To Haves

Bachelors degree in a scientific field and industry experience is preferred.

Responsibilities

Reviews manufacturing related documentation to ensure processes adhereance and compliance with approved SOP’s and cGMPs.
Responsible for performing inspection readiness walk-throughs, line clearance and in-process checks in support of manufacturing activities
Provides QA support for manufacturing and testing activities including: shop floor oversight, deviation and laboratory investigations, change management, SOP revisions and batch documentation reviewProactively identify and address non-conformances in manufacturing operations
Able to work in a team environment within own team and interdepartmental teams independently, with minimal guidance and under short timelines while maintaining quality work.
Collects, reports and is responsible for departmental data.
Alerts management promptly to any issues identified during batch production / record reviews that may adversely impact manufactured products, demonstrating accountability and a commitment to maintaining high-quality standards.
Reviews SOPs, Forms, Logbooks, and Master Batch Records to ensure accuracy and compliance with established procedures.
Participates in internal GMP audits and supports customer and regulatory audits.
Assists in training Quality Assurance colleagues.
Has the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing areas.
Performs ERP transactions, as applicable.
Must be willing to work overtime and weekends as needed to support business initiatives.
Other tasks assigned by management.