Night QA Manufacturing Specialist I/II cGMP & BatchRecords

KBI Biopharma; Boulder (CO); Vor Ort; USD 67.000 - 85.000; Vollzeit

Zusammenfassung

KBI Biopharma is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards and government regulations. This role provides broad QA oversight for activities supporting bulk drug substance manufacturing.

Responsibilities include review and approval of batch records, SOPs, deviation investigations, and collaboration with GMP teams to resolve deviations promptly. Night shift with shift differential.

Qualifikationen

• Bachelor’s degree required with 2 years of experience for QA Specialist I
• Bachelor’s degree with 6 years of experience for QA Specialist II
• Experience in a cGMP QA environment or equivalent preferred

Aufgaben

• Perform compliance review on batch and solution records, on-the-floor data, and logs
• Author or revise Standard Operating Procedures (SOPs), forms/logs, and batch/solution records
• Support manufacturing changeovers and resolve deviations with GMP teams
• Review, approve deviation investigations and batch records for QA release
• Assist QA Raw Material team with raw material release as needed

Kenntnisse

Quality assurance

GMP compliance

Documentation review

Deviation investigations

SOP writing

Ausbildung

Bachelor's degree

Jobbeschreibung

KBI Biopharma is seeking a Quality Assurance Specialist I/II Manufacturing to ensure products, processes, facilities, documentation, and systems meet quality standards and government regulations. This role provides broad QA oversight for activities supporting bulk drug substance manufacturing.

Responsibilities include review and approval of batch records, SOPs, deviation investigations, and collaboration with GMP teams to resolve deviations promptly. Night shift with shift differential.