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Senior Quality Specialist

Boston, MA 02210

Posted: 01/17/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 529364 Is job remote?: No Country: United States

Job Description

Pay Rate Range: $40-$45/hr

General Summary:

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives.

Key Duties and Responsibilities:

· Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.

· Supports change control assessments, implementation and closure

· Identifies and facilitates continuous improvement efforts

· Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed

· Helps represents Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.

· Support continuous improvement projects

Knowledge and Skills:

· Experience supporting multiple projects/teams within stated objectives and timelines

· Experience supporting cross-functional team members and collaborate effectively

· Good communication skills (written and verbal) and the ability to exchange potentially complex information

· Able to integrates activities with other groups, departments and project teams as needed

· Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent

· Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives

· Expanded conceptual knowledge of cGMP's in a pharmaceutical setting

· Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Education and Experience:

· Bachelor's degree in scientific or allied health field (or equivalent degree)

· Typically requires 2 years of experience, or the equivalent combination of education and experience
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