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Shire Quality Associate III - Compliance Lead in Social Circle, Georgia
This position is responsible for supervising Event and CAPA Investigation Record processing, along with other compliance activities, within the Shire Georgia QC analytical laboratories. Must be able to handle multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.
1) Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
2) Own CAPA investigations and supervise other CAPA investigators to complete records in an efficient, accurate and timely manner.
3) Oversee the training program for the analytical laboratories and ensure that training is compliant with company requirements and regulations.
4) Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements.
5) Lead in the development of customer awareness and understanding activities for areas of direct responsibility and, where appropriate, assist and support such activities throughout the facility.
6) Propose and obtain approval for effective corrective and preventive action plans and ensure that the action plans are implemented and measured.
7) Work closely with Quality Control and Quality Assurance leadership to achieve goals for timeliness and quality compliance of associated records.
8) Support continuous improvement of CAPA system consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations.
10) Complete other duties as assigned by Quality Control Manager.
11) Must be able to work efficiently in a cross-functional team environment.
Understand scientific strategies and be able to implement new methods or new avenues of investigation.
Good interpersonal/communication/influencing/negotiating skills. Good project management skills. Advanced technical writing ability.
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Experience with investigational/problem solving tools like DMAIC, Six Sigma, and Lean operations.
Education and Experience:
Minimum of a Bachelor's degree in science, engineering or related field with a minimum of 5 years of pharmaceutical industry experience.
Experience in Quality Operations with emphasis on nonconformance investigations and problem solving techniques, as well as, interpreting regulations and quality systems.
Requires previous investigation leadership experience.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire 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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Shire 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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.