QA Compliance & CAPA Specialist II

American Regent, Inc.

New Albany (OH)

On-site

USD 70,000 - 100,000

Full time

4 days ago

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Job summary

American Regent, Inc. is seeking a Compliance Program Specialist II to advance the QA Compliance program across Ohio sites.

Reporting to the QA Compliance Program Manager, this role coordinates CAPA, internal audits, and customer complaint processes in a cGMP manufacturing environment. You will partner with cross-functional teams in production, labs, facilities, and engineering to ensure regulatory alignment, data integrity, and timely issue resolution, while supporting inspection readiness and

Qualifications

Bachelor's degree in Life Science, Statistics or related field required or equivalent years of experience.
Minimum of 3 years of work experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment is required.
Experience across multiple areas including developing quality system requirements for cGMP compliance and validation.
Knowledge of US regulations and ability to interpret/apply to the organization.
Six Sigma Green Belt certification preferred.

Responsibilities

Execute and maintain Internal Audit Program.
Work with Functional Area Management and cross-functional teams to ensure procedural compliance and alignment with regulatory requirements.
Execute and maintain Compliance CAPA System and verify effectiveness.
Work with owners and cross-functional teams to ensure Corrective Action Plans are implemented and verified.
Execute and maintain Customer Complaints Program in Ohio including metric reporting.