Senior QA Specialist Job Description
The Senior QA Specialist is a key member of the team tasked with ensuring the successful day-to-day operation and management of Quality Operations and Quality Management System (QMS) for the facility. This role also supports other organizational objectives.
Essential Functions/Responsibilities:
* Represent Quality during manufacturing operations, providing guidance and resolving issues in a collaborative fashion.
* Ensure operational quality support for production, guaranteeing the manufacture of quality products in accordance with product licenses and filings.
* Perform production on the line AQLs and incoming inspection, and disposition of raw materials, consumables, packaging.
* Review manufacturing-related documents in accordance with facility requirements.
* Implement and oversee quality systems, ensuring compliance with regulatory guidelines and company policies.
* Provide quality and cGMP input and oversight of the manufacturing facility, including data integrity.
* Manage and support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials.
* Generate Quality Systems metrics and prepare presentations for Senior Management review.
* Generate and approve Quality documents.
* Support validation activities, reviewing and approving technical support documentation.
* Manage a QMS system to ensure compliance and adherence to site metrics.
* Manage QA responsibilities of external manufacturers of APIs.
* SUPPORT site compliance program, performing internal audits and implementing audit action plans.
* Participate and follow-up in third-party audits and/or inspections carried out at the site by authorities or clients.
* Partner with other company SMEs to understand and respond to changes in the regulatory environment.
* Lead initiatives and action plans for QA development and GMP compliance improvement.
Required Knowledge, Skills, and Abilities:
* 4-7 years' experience working in finished product pharmaceutical/biologics manufacturing, analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
* Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
* Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence, and lead.
* Demonstrated capability in establishing collaborative working relationships at all levels.
* Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems.
* Recognize areas for improvement and use initiative to implement change programs.
* Ability to work independently and as part of a team in a dynamic environment.
* Ability to deliver objectives on time while meeting compliance and cost targets.
* Ability to generate high-standard documentation.
Preferred Knowledge, Skills, and Abilities:
* Demonstrated expertise in Data Integrity highly desirable.
* Working experience in SAP and LIMS highly desirable.
* Experience in participation in regulatory audits (HPRA or FDA) desirable.
Required/Preferred Education and Licenses:
* BSc in science discipline required.
* Lead auditor certification highly desirable.
* Qualified Person experience or educational requirements desirable.