Senior Quality Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Pay Rate Range: $40-$45/hr
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
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.