US-GA, Quality Assurance Specialist II SR0032756-MZ
Support Quality Systems processes (e.g. Investigations, CAPA, Change Control, Management Review, FCA, Complaint handling, Plasma Lookback Process, etc) and prepare and communicate Quality Systems performance metrics.
Assist plant wide departments with Quality Systems processes (e.g. Investigations, Change Control, Management Review, FCA, Complaint handling, Lookback Process etc) .
Participate in continuous improvement initiatives.
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 are conducted as required by the relevant procedures.
Supports customer complaint response and tracking.
Maintain expertise in quality systems and quality processes
Assist with revision of standard operating procedures as assigned by management.
Participate and lead projects within the department as assigned by management
Data entries, maintains and administer databases, build queries and prepare/ issue reports
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
Prepare and communicate monthly performance metrics
Provide training within the department and to other department employees (e.g. NEO,GEMS, Change Control, Compliance, GMP )
Technical writing skills
Problem solving skills
Understanding of manufacturing processes and/or quality systems elements
Experience in utilization of Quality Systems such as TrackWise, VEEVA
Demonstrates strong communication skills (verbal and written)
Data analysis skills are required
Bachelor s degree
(Degree in the life sciences, engineering and 2 to 5 years experience with a medical device / pharmaceutical or other similarly regulated industry preferred)
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Please visit our website at takedajobs.com