What are the responsibilities and job description for the QA Specialist, Batch Record Management position at Renaissance Lakewood LLC?
- Ensure batch records (and related documents) are written accurately so that end users can follow them and ensure appropriate training of those records 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 and associated documents.
- Interact with other departments and customers to ensure batch record (and associated documentation) precision and alignment.
- Prepare monthly and quarterly quality metric presentations.
- Support client audits and regulatory inspections.
- Lead and support process improvement teams within the company.
- Appropriately analyze batch record mistakes and related deviations to determine effective and sustainable corrective and preventive actions. Take action as needed to sustain quality product/production.
- Create/Maintain procedures for batch record management/creation for products in all stages of development and commercialization.
- Responsible for staying on task related to the production schedule, ensuring records and forms are available as needed.
- Any other tasks assigned by management.
