Quality Assurance Technician

Our Work Matters:At Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeQA 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 ResponsibilitiesReviews manufacturing related documentation to ensure processes adhereance and compliance with approved SOPs and for performing inspection readiness walk-throughs line clearance and in-process checks in support of manufacturing activitiesProvides 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 operationsAble 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 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 SOPs Forms Logbooks and Master Batch Records to ensure accuracy and compliance with established in internal GMP audits and supports customer and regulatory in training Quality Assurance the ability to understand and demonstrate aseptic techniques and behaviors required in aseptic processing ERP transactions as be willing to work overtime and weekends as needed to support business tasks assigned by QualificationsHS/GED. Bachelors degree in a scientific field and industry experience is individual must have strong attention to detail and organizational individual must be able to follow instructions and proceduresBasic knowledge of cGMPs (USFDA Health Canada PIC/S and/or Eudralex).Demonstrated decision making ability with emphasis on overall quality site priorities results and well in a team environment within own team and interdepartmental work under short timelines while maintaining quality have effective written and oral communication skills.#LI-onsite