The Planet Group
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http://www.theplanetgroup.com
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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
Senior Quality Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Posted: 01/17/2023
2023-01-17
2023-02-25
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 529364-1
Country: United States
Is job remote?: No
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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