Specialist QA

Amgen; United States; Remote; USD 85,000 - 110,000; Full time

Job summary

A leading biotechnology company is seeking a Specialist QA (Quality Systems) to ensure compliance and oversight of quality systems. In this senior role, you will leverage your expertise to develop quality management processes, support regulatory initiatives, and enhance operational excellence within a dynamic environment.

Qualifications

• Relevant experience (8yrs +) in pharmaceutical or biotechnology industry.
• Demonstrated ability in managing Root Cause Analysis/Deviation investigations.

Responsibilities

• Oversight of quality systems, Change Control and Deviation Review Boards.
• Responsible for trending programs associated with Deviation/CAPA and Quality Risk Management processes.

Skills

Excellent written and verbal communication skills

Strong organizational skills

Problem solving

Education

University degree in Engineering or Science

Job description

Career Category Quality Job Description

Specialist QA (Quality Systems) 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.
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.

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

• Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
• 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.
• 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 associated to Amgen Quality Systems.
• 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.
• 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 site.

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.

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