Shire Supervisor, Quality Assurance 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.

Summary:

The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification and fill finish for its biologic medications.

Supervises a staff of QA Associates that are responsible for providing Quality Assurance support for Fractionation process and providing Quality oversight and manufacturing support as required by Operations and timely review of BR documents on the shop floor. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practices

This responsible person will use of Electronic Batch Management (EBM) and will also provide guidance to other team members.

This position will support Off Shift once the facility is ready for shift coverage

Essential Duties and Responsibilities:

  • Plans and schedules the work of QA Associates.

  • Support supervision for the floor coverage (as needed) and lead daily departmental operations.

  • Supervises a staff of QA Associates to ensure compliance with manufacturing procedures are flowed on the floor.

  • Supervising the staff to ensure that production records are reviewed established targets .

  • Provide Training and coaching for the department

  • Work closely with Production Supervision, Other QA Operations Groups, Quality Systems, and Engineering to ensure adequacy and appropriateness of product specifications.

  • Provide support towards engineering runs and validation activities. .

  • Review electronic batch records, identify nonconformance’s and participate in investigation and Corrective and Prevention Action(CAPA) activities

  • Provide training and coaching to local employees and others as needed on relevant area(s).

  • Write, review, revise, and approve written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

  • Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

  • Participate in QA multi-site projects in the role of contributor, coordinator or lead.

  • Other duties, tasks or projects as assigned.

Working Environment:

  • Will be spending large portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.

  • May be required to work weekends, evenings, off-hours, and extended periods of time.

  • May be required to travel to local and international work locations for extended periods of time for training.

Qualifications:

Education and/or Experience

Bachelors degree in Engineering, Science or related field or equivalent. Minimum of 4 years of QA experience in the life sciences and experience with a medical device / pharmaceutical or other similarly regulated industry preferred.

  • Strong interpersonal/communication/influencing/negotiation skills

  • Strong analytical and problem solving skills.

  • Must have the ability to encourage teamwork and drive decisions.

  • Must be able to handle multiple projects concurrently.

  • Requires scientific and technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations

  • Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required

  • Knowledge of Electronic Quality Systems( TrackWise), Process control systems (Delta V, BAS) and Electronic Batch Record Management preferred

  • Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

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.