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Summary of Position

The Quality Assurance Specialist position is responsible for product oversight, material release, technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will provide QA oversight to production on the floor, batch release and Quality Events. This position reports to the Senior Director of Quality.

Essential Functions

Review and edit documents for accuracy, completeness, and consistency.

Perform QA on the Floor function.

Gown into a grade C and D environment.

Monitor aseptic operations for Quality Assurance.

Review batch record completeness for accuracy and compliance.

Review and release incoming materials for accuracy and compliance.

Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.

Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).

Support regulatory and client audits.

Conducts internal audits of the QMS and sub systems.

Analyze data to identify areas for improvement in the quality system.

Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

Bachelor Degree in Science or related field required.

3 or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance

Knowledge of tools, concepts and methodologies of Quality.

Auditing experience, along with deviation and lot release support.

Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems

Working knowledge of cGMP guidelines.

Proficient in use of Microsoft suite of products.

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