Quality Records & Compliance Specialist

AmerisourceBergen Pharmaceutical Distribution and Strategic Global Sourcing; Shakopee (MN); On-site; USD 52,000 - 82,000; Full time

Job summary

Cencora, supporting AmerisourceBergen distribution services in the US, seeks a quality assurance professional. You will manage controlled quality documents, monitor CAPA milestones, and prepare materials for internal and external inspections.

A strong focus on data accuracy and cross-team collaboration is essential. Require 3+ years in quality-related roles, with a HS diploma or equivalent, and preferably CQIA or ISO 9001 Lead Auditor certification.

Qualifications

• High School Diploma/GED or equivalent experience required.
• Associate's degree in business administration, quality, or a related field, or equivalent experience preferred.
• 3+ years of experience in quality assurance, quality control, compliance, manufacturing quality, supplier quality, or a related field required.
• CQIA or equivalent certification (ISO 9001 Lead Auditor preferred).

Responsibilities

• Coordinates the tracing, circulating, and filing of controlled quality documents to preserve accurate maintenance of the enterprise quality management system.
• Traces CAPA milestones and remediation tasks to collaborate with staff in recording compliance timelines.
• Compiles routine audit readiness materials and logistical arrangements to reinforce inspection activities.
• Enters daily data and checks validation of quality metrics within databases to guard reporting accuracy and traceability.
• Resolves standard administrative quality inquiries and workflow interruptions to preserve day-to-day operational continuity.

Skills

Quality assurance

CAPA tracking

Documentation management

Audit readiness

Education

High School Diploma/GED or equivalent

Associate's degree in business administration, quality, or related field

CQIA or ISO 9001 Lead Auditor certification

Job description

Cencora, supporting AmerisourceBergen distribution services in the US, seeks a quality assurance professional. You will manage controlled quality documents, monitor CAPA milestones, and prepare materials for internal and external inspections.

A strong focus on data accuracy and cross-team collaboration is essential. Require 3+ years in quality-related roles, with a HS diploma or equivalent, and preferably CQIA or ISO 9001 Lead Auditor certification.