QA Specialist, Regulated Manufacturing (Hybrid/Remote)

ProQuality Network; Coffeyville (KS); Híbrido; USD 70.000 - 120.000; Jornada completa

Descripción de la vacante

ProQuality Network seeks a Quality Assurance Specialist to support its regulated manufacturing QA program with minimal supervision. The role focuses on compliance with regulatory requirements, internal procedures, and industry standards within a regulated environment.

Preferred qualifications include advanced degrees and experience in aseptic processing, validation activities, and QA systems; strong cross-functional collaboration is required to drive site quality initiatives.

Formación

• Master’s degree with 2+ years in life sciences or engineering or related field.
• Bachelor’s degree with 4+ years related experience; advanced degree preferred.
• Experience in regulated manufacturing environments and QA activities.

Responsabilidades

• Review and approve MPs.
• Review and approve process validation protocols and reports.
• Serve as Quality representative on the incident triage team.
• Review and approve Environmental Characterization reports.
• Lead quality investigations, including non-conformance (NC) and CAPA records.
• Lead and participate in site audits.
• Own and manage site quality program procedures.
• Act as QA Manager designee on the CCRB.
• Review and approve risk assessments.
• Support automation, facilities, and environmental programs.

Conocimientos

Cross-functional teamwork

Project management

Regulatory knowledge

Data analysis

Educación

Master’s degree + 2 years of related experience

Bachelor’s degree + 4 years of related experience

Associate degree + 8 years of related experience

High School Diploma/GED + 10 years of related experience

Descripción del empleo

ProQuality Network seeks a Quality Assurance Specialist to support its regulated manufacturing QA program with minimal supervision. The role focuses on compliance with regulatory requirements, internal procedures, and industry standards within a regulated environment.

Preferred qualifications include advanced degrees and experience in aseptic processing, validation activities, and QA systems; strong cross-functional collaboration is required to drive site quality initiatives.