Associate QA Specialist Batch Record Management

Responsible for the quality aspects of batch record management etc. per cGMP and company standards. This includes the writing, editing, processing, and gaining approval of the Master Batch Record (MBR). To interact with internal clients in regard to batch record management at all stages of development and commercialization (development, clinical, and commercial). Ensure that batch records are accurate, effective, and efficient for the user.

Ensure batch records (and related documents) are written accurately in a manner that end users can follow them and ensure appropriate training of those record and related documents.

Ensure activities related to batch record management and associated documentation are performed in a timely manner.

Develops and reviews batch record creation and revisions, as well as associated documents.

Maintain a strong presence on the manufacturing floor to observe, evaluate, and support continuous improvement of the current production practices.

Interact with other departments and customers to ensure batch record (and associated documentation) precision and alignment.

Support client audits and regulatory inspections.

Support process improvement teams within the company.

Appropriately analyze batch record mistakes and related deviations in order to determine effective and sustainable corrective and preventive actions. Take action as needed to sustain quality product/production.

Create/Maintain procedures related to batch record management/creation related to products in all stages of development and commercialization.

Responsible for staying on task as related to the production schedule, ensuring records and forms are available for use as needed.

Any other tasks assigned by management.