Shire Jobs

JOB REQUIREMENTS: Work Location: Sheboygan Falls, Wisconsin Shift: Department: LS-SC-PMSQA2 Sheboygan QA2 Recruiter: Michelle Cole Hiring Manager: Kerry Frederickson This information is for internals only. Please do not share outside of the organization. Your Role: The Quality Assurance Specialist will facilitate and support the development, maintenance, and improvement of quality systems, to ensure their alignment with business goals, customer expectations, and requirements for global business unit best practices. This position will have a strong focus in Supplier Quality Management and general Quality Management System requirements and improvements. Responsibilities to include the following: Quality system development and maintenance activities Support supplier quality management activities and programs Lead and facilitate supplier development activities including audits Lead, facilitate and support various quality system initiatives Physical Attributes: View computer monitors for long periods of time Regular use of phones, computers, computer monitors and office equipment Who you are: Minimum Qualifications: Bachelor\'s degree in science, engineering, or business/mathematics including course work in chemistry or other science discipline OR High School Diploma and 3+ years of work experience in a quality role or 5+ years in a production, or project management role Preferred Qualifications: 3+ years of knowledge and experience in Quality Management Systems, ISO Quality Standards, and other regulatory standards as appropriate. (FDA, VDA, DOT, IATA, DEA, etc.) 1+ year of knowledge and experience in 21CFR117 Hosting and performing internal and external audits Understanding of data analysis, presentation, and experimental design Ability to work independently and in a fast-paced, team environment Ability to simultaneously manage multiple tasks and priorities Understanding of current processing requirements for food, drug, industrial, and biologic types of products Demonstrated leadership and strong problem-solving skills Excellent oral and written communication skills Strong computer skills Life science, Chemical, Food Industry, or Healthcare industry knowledge Knowledge of SAP, TrackWise, Document Control Systems, and Microsoft Office Experience in preparing and reviewing documentation to ensure compliance with company or customer quality requirements Ability to increase efficiencies in the continuous improvement of the quality management system The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjU0NjM3Ljg3NzBAZW1kbWlsbGlwb3JlY29tcC5hcGxpdHJhay5jb20