Job Title: Senior Quality Assurance Specialist
Job Summary:
We are seeking an experienced Senior Quality Assurance Specialist to join our team. As a key member of our Manufacturing Quality Compliance team, you will be responsible for performing critical quality and compliance tasks.
Key Responsibilities:
* Review internal and external Standard Operating Procedures (SOPs) relevant to manufacturing compliance quality and participate in their development and revision.
* Lead the generation of Quality Management Review (QMR) reports for review and presentation to senior management.
* Support the coordination and implementation of the Internal Audit plan and Vendor audit plan for GDP/GMP activities.
* Support inspection readiness and inspection activities, including performing one or more inspection roles during an inspection.
* Perform auditing to support the Internal Audit plan.
* Lead the maintenance of the inspection readiness toolkit, training materials for internal and external teams.
* Monitor trends in regulatory inspection activities, the Internal Audit program, and GMP regulatory changes.
* Support the management of GMP Regulatory Changes/Quality Intelligence assessments.
* Lead the management of the Quality and Technical Agreement (QTA) process and maintain the master list of QTAs.
* Contribute to the development of continuous quality process improvement.
* Collaborate with other departments and customers to ensure compliance and productive working relationships.
* Maintain current training in accordance with the company's training curriculum.
* This position may require up to 10-20% travel.
Requirements:
* Experience working in finished product pharmaceutical/biologics, including analytical chemistry, quality systems, quality assurance, quality control, and/or manufacturing areas.
* Excellent oral and written communication skills.
* Proven experience in data analysis and presentation.
* Ability to present to senior management.
* Thorough understanding of quality systems and cGMP regulations.
* Strong interpersonal and professional skills to interact at all levels.
* Competency in using methods and tools to assist with Manufacturing Quality Compliance metrics.
* Ability to work effectively in a team environment.
Education and Licenses:
* Bachelor's degree in chemistry, biology, or a related discipline.