**Job Title:** QA Manufacturing Compliance Specialist
We are seeking an experienced QA professional to join our client's aseptic facility in this critical role.
Key Responsibilities:
* Ensure all products meet the required standards for marketed and investigational drug products.
* Guarantee products and aseptic process simulations manufactured meet end-user, regulatory authority, and company requirements.
* Provide quality and compliance oversight to Operations, ensuring manufacturing processes comply with site policies and procedures.
* Offer quality oversight during aseptic processing, including intervention observation.
* Lead/assist in investigations arising from product or manufacturing process non-compliance.
* Review/Audit completed Batch Records.
* Review Manufacturing Logs as needed.
* Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
* Perform Line Clearance activities.
* Conduct Incoming Raw Material checks, including product status maintenance (as required).
* Support Stability Program, e.g., sample pulls, weekly checks, protocol generation (as required).
* Maintain finished product status, including labeling (as required).
* Administer Quality Logs, e.g., QA Hold, Sample Request.
* Lead daily walk around of manufacturing areas.
* Drive continuous improvements, simplifying site processes and procedures to ensure compliance at all times.
Requirements:
* Bachelor's degree in science, quality, or engineering discipline.
* Prior experience in a quality role is ideal.
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment.
* Experience in biologics manufacturing is highly desirable.
* A strong knowledge of regulatory requirements is necessary.