QA Compliance Specialist I

Role Summary

QA Compliance Specialist I performs compliance activities in support of production and engineering to ensure all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. Provides floor support to production departments, including line clearances, in-process checks and investigations. Participates in quarterly audits and internal, customer, and regulatory audits as part of the Audit Team.

Responsibilities

• Review and approve supplemental logs, charts and other documents in support of cGMP operations
• Review batch records for accuracy and completion prior to final release of product
• Perform product releases for fills and intermediates lots

Coordinate product releases with distributors and customers as needed

Qualifications

Skills

Education

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