Shire Quality Associate II in Social Circle, Georgia

  • Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. 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

  • Support Quality Systems processes (e.g. GEMS, 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. GEMS, Change Control, Management Review, FCA, Complaint handling, Lookback Process etc) .

  • Participate in continuous improvement initiatives.

  • Coordinate and assist with GEMS events (workflow A and workflow B)

  • Review and approve Insignificant and Significant Change Control records.

  • Ensure that Management reviews are conducted as required by the relevant procedures.

  • Coordinates 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 entry, maintain 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 )

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)

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.

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/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.