QA Manufacturing Compliance Specialist (Biologics)
Key Responsibilities:
* Ensure that all products leaving the site meet the standards required for marketed and investigational drug products.
* Ensure that products and aseptic process simulations manufactured at the site meet the requirements of the end users, regulatory authorities, and the company.
* Provide quality and compliance oversight and assistance to the Operations function to manufacture products in compliance with all site policies and procedures.
* Lead/Assist in investigations arising out of product or manufacturing processes non-compliance.
* Review/Audit of completed Batch Records and Manufacturing Logs as required.
* Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments) and Line Clearance activities.
* Completion of Incoming Raw Material checks and Provide Stability Program Support.
* Manage Finished product status maintenance and Administration of Quality Logs.
* Drive continuous improvements and simplify site processes and procedure to ensure compliance is maintained at all times.
Requirements:
* Third-level degree in a science, quality, or engineering discipline.
* Prior experience in a quality role is highly desirable.
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment, preferably in biologics manufacturing.
* Strong knowledge of regulatory requirements is essential.