US-GA, Sr Quality Assurance Specialist SR0032755-MZ
Execution Lead for the Quality System element(s) assigned:
Ensures that the Quality System elements assigned comply with the global process and regulations.
Collaborate and communicate with global function and sister sites to align on goals and best practices.
Leads site continuous improvement initiatives.
Ensures that quality system metrics / trends are reported as established by the site and/or internal Quality System metrics.
Leads ongoing daily departmental activities
Provide training, guidance, and coaching for Quality System staff supporting Quality System element(s) assigned
Assists other departments in understanding the achievement of quality goals in an efficient, accurate, compliant and timely manner.
Participate in DMAIC projects in the role of contributor, coordinator or leader.
Support site audit and inspections (e.g. Internal Audits, FDA and other regulatory body inspections)
Perform compliance related activities (e.g .walkthroughs, local audits and compliance reviews, GMP training)
Coordinate and assist with TrackWise system deviations
Review and approve Insignificant and Significant Change Control records.
Ensure that Management reviews and Product Quality Reviews (PQR) are conducted as required by the relevant procedures.
Coordinates customer complaint response and tracking.
Maintain expertise in quality systems and quality processes
Participate and lead projects within the department as assigned by management
Write, review and approve new or revised procedures.
Participate in internal or external assessments, as required.
Communicates with other managers (cross functional) for process improvements, alignment of quality concepts
Provide training within the department and to other department employees (e.g. NEO,GEMS, Change Control, Compliance, GMP )
Understand and able to perform all the primary activities as defined in QAI and QAII jobs
Strong technical writing skills
Sound decision making and problem solving skills
Understanding of manufacturing processes
Understanding of quality systems element
Proficient in utilization of Quality Systems such as TrackWise, VEEVA
Demonstrates solid communication skills (verbal and written) with management and peers and be able to work cross-functionally with other groups.
Must demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues
Solid presentation skills are required.
Data analysis skills are required
Bachelor degree in science, engineering or other technical field.
Five (5) + years related experience
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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