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Associate Director, Quality Assurance- Pharmaceutical Manufacturing

Akorn, Inc

This is a Contract position in Logan, WV posted November 24, 2021.

SUMMARY: Responsible for cGMP compliance ensuring all FDA regulations, internal procedures and other regulatory requirements are adhered to as it relates to production support and documentation.

Ensure all commercial products manufactured, processed, packed or held at the site meet requirements for product identity, strength, quality, and purity, including products for regulatory submission.

In addition, manage, direct, and mentor QA staff.

ESSENTIAL FUNCTIONS: Develop, implement, sustain, and improve QA production support to meet FDA regulations, ICH, internal procedures and other regulatory requirements, while maintaining customer satisfaction.

Ensure Quality Assurance Production Support include written procedures to ensure QA has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging/labeling materials, and drug products.

This includes review and approval of all records impacting the identity, strength, quality and purity of materials per 21 CFR parts 210 and 211.

Oversight of the release of raw materials, packaging components, and finished product.

Evaluate personnel requirements of the quality assurance, as it relates specifically to QA production support (room clearances, batch release, material release, etc.).

Oversee QA documentation (issuance of batch records, SOPs, change controls, etc).

Support, as necessary, product release and cross-train with quality systems counterpart.

Administer the site quality assurance program as delegated by the Executive Director
– QA/QC.

Assure consistency of purchased components by vendor certification, establishment of effective acceptance criteria, and product monitoring.

Administer and support program for annual product reviews for all commercial products.

Act as a delegate/assigned designee to perform functions on behalf of the Executive Director, Quality as it relates to Quality Assurance production support and documentation.

Responsible for the overall direction, coordination and evaluation of this unit.

Directly supervises Manager for Documentation, QA Supervisors, and QA Batch Release Supervisor.