Shire Quality Lab Assoc III 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.

Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.

Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.

·Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizan, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.

Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements

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.

Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.

Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.

Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis

Assists and writes validations for equipment, product changes and computer systems.

Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.

Understand scientific strategies and be able to invent new methods or new avenues of investigation.

· Good interpersonal/communication/influencing/negation skills.

· Good project management skills

· Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Qualifications:

Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal. Lead Auditor training, ISO Lead Assessor training, with 2-3 years experience in auditing techniques, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.

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.