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Job Description

Specialist QA (Quality Systems & Compliance)

Job Description Summary

The QA Specialist is a senior & active role within the broader QA function. The QA Specialist will typically report to a QA Senior Manager & will be required to be a Subject Matter Expert in their assigned area of responsibility. QA Specialists will be required to understand & grasp a broad range of quality related competencies.
 

In addition to routine QA duties, QA Specialists may be assigned specific oversight & responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within ADL; including Supply Chain, Operations Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control.

Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

General QA Specialist Responsibilities:

• Perform all activities in compliance with Amgen safety standards and SOPs
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures (SOPs) in accordance with Amgen Standards.
• Participate in site activities associated with QMS programs (e.g. Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
• Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations.
• Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.

Quality Systems and Compliance Specialist (may perform some/all of these duties):

• Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and auditing related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, Internal auditing/self-inspection program, Regulatory Inspection Management, oversight of computerised systems supporting Quality Management System and the overall Quality Management review process.
• Ensuring that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site.
• Oversee and maintain site Inspection readiness program and for hosting of inspections (self-inspection and regulatory/corporate inspections).
• Manage inspection outcomes, including inspection response compilation and tracking.
• Oversee and implement Quality Agreements relating to area of responsibility.
• Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines.
• Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
• Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
• Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
• Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
• Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance.

In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience and knowledge.

Basic Qualifications

• University degree. Engineering or Science related discipline preferred.
• Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

Preferred Qualifications

• Excellent written and verbal communication skills
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.