Full job description
Job Description:
The Quality Systems Sr. Specialist is an experienced technical resource in the principles and application of quality systems and compliance. The Quality Systems Sr. Specialist coordinates or executes activities on projects and takes a role in the execution and improvement of processes.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Responsible for supporting local Quality system oversight, metrics, and improvement including change control, events, CAPA, and risk management.
- Responsible for supporting functional quality oversight for Change Control Management Program including change control board/triage process.
- Responsible for supporting follow up on any Quality Leadership Team (QLT) meeting action items assigned.
- Coordinates and/or supports the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans.
- Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions.
- Provides hands-on support in the day to day management of data collection systems and control within the GxP Quality Management System using digital solutions.
- Assists with Quality and Risk Management initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes.
- Assists Change Control, deviation, and CAPA owners with ensuring compliance to change procedure requirements.
- Supports internal audit or external audit programs.
- Identifies and implements continuous improvement to improve processes and make them efficient and scalable.
Minimum qualifications:
Knowledge and Skills:
- Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; knowledge of global GMP requirements and support of GMP manufacturing.
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
- Experience implementing projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
- Ability to represent the Quality unit in cross-functional teams.
- Ability to communicate cross-functionally and gain alignment around a proposed action.
- Demonstrated ability to work independently to provide QA support for projects.
- Demonstrated ability to evaluate quality matters and recommend solutions leveraging technical experience and judgement.
- Experience with event investigations, Root Cause Analysis (RCA), and CAPA.
- Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva).
Education and Experience:
- Bachelor‘s degree in a scientific or allied health field (or equivalent degree).
- Typically requires 3 years of experience, or the equivalent combination of education and experience.
Pay Range:
$45-$55/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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