Role is responsible for non-laboratory activities that ensure overall effective QC operations: specification document management, CoA generation, non-routine protocol review and coordination, LIMS builds, inspection preparation and support activities, and critical sample management. Additionally, the role supports Quality projects and implementation of operational excellence initiatives.
This role supports the site laboratories, as well as key partners in the global Quality organization.
• Lab scheduling - work with laboratory managers to ensure on time testing based on site priorities
• Metrics - report routine metrics for QC information centers
• Specification management - work with stakeholders to implement new/revised specifications for drug substance and drug product
• CoA generation - approve certificates of analysis for drug substance and drug product
• Inspection support - support inspection preparation activities as well as provide resources for inspection management
• Non-routine protocol review and LIMS builds - coordinate review of non-routine protocols and LIMS builds in support of AD/PD or investigational programs
• Critical sample management - Oversight of storage of retains, reserves, and reference standards for internal programs and specified external programs
• Cold strategy - monitor QC cold storage capacity and ensure sustainability for storage of an expanding portfolio of critical samples
• QC archiving - Oversee archival program for QC records
• Coaching and development of junior staff in order to provide personal growth and business continuity
Education & Experience Requirements:
Essential: Minimum bachelor of science degree in a technical field, 10+ years of relevant experience in a GMP manufacturing or laboratory environment.
Familiarity/use of lean six sigma methodology.
Use of LIMS.
Desired: Previous supervisory experience
Other Job Requirements:
• Limited to no travel expected. Travel between sites is required.
• The following physical abilities are required in order to fulfill the job duties:
-Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
-Ability to work around chemicals (if working in/around the laboratories)
-Ability to wear personal protective equipment such as lab coat, gloves, and/or gowning
-Ability to walk and stand for periods of time
-Individual required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.