Sr Quality Manufacturing Quality Operations Specialist
Sr Quality Manufacturing Quality Operations Specialist
Boston, Massachusetts(Hybrid)
Phone+Skype
Long Term Contract
JD:
Key Responsibilities:
*** MUST be a " Critical Thinker , HAVE OUTSIDE CMO / SUPPLIER / VENDOR Agreement experience !!! 0- ( Two past manager references MUST verify this !!)
*** MANUFACTURING experience
*** SMALL MOLECULE Experience
Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result associated with 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.
Performs the review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data
*Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods.
*Supports GMP document review, including certificate of analysis, specifications.
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