Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians, and all others who support and advance their care. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
The individual will successfully perform all the primary duties as defined in Quality Analyst I job position. This includes supporting the labeling design and development operations across multiple projects and in a timely manner.
The individual shall demonstrate effectiveness in task completion, decision-making, implementation of procedural and process improvements, training, problem-solving, and team leadership.
Additionally, the individual will have functional understanding of FDA, ISO, and Shire Quality systems.
This position will also support cross-functional/divisional projects and initiatives, including those associated with product development, special projects, process improvement efforts, and training teams.
Essential Duties/ Responsibilities:
•Responsible for reviewing pertinent documents, records and reports against Standard Operating Procedure (SOP) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.
•Support multiple process/product improvement projects, other focus groups, validations, investigations, development and implementation of new and/or improved business processes and systems with a global focus, data generation, report development, and presentation.
•Review or revise SOPs and specifications.
•Identify areas of non-conformance and inform management via drafting of event records as needed to be disposed (unilaterally accepted or rejected by others.
•Performs initial investigative actions on some events, applying well-established techniques and procedures.
•Provide input to management as to project cost; monitor all cost within budget. Notify management of all issues.
•Lead and support on-going daily department activities.
•Maintain communication with supplier, providing on-going feedback related to quality issues; assist with supplier audits/assessments.
•Maintain a high level of expertise in current regulatory requirements and serve as a resource for compliance to requirements.
•Support the development of customer awareness and understanding of activities for areas of direct responsibility.
•Develops, gathers, and evaluates relevant quality and productivity metrics.
•Supports innovation within areas of responsibility by implementing continuous improvement opportunities with the objective of achieving operational excellence.
• Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed. Participates in, manages key responsibilities, and acts as SME for area(s) of expertise during external and internal inspections. This can include maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
Qualifications & Education/ Experience:
-Bachelor degree or equivalent with 1-3 years in the life sciences, business or other technical field (preferred). An equivalent combination of education and experience (3-5 years), preferably in pharmaceutical labeling and/or quality operations is also acceptable.
-Experience in Graphic Arts and/or labeling artwork development is strongly recommended. Experience in the area(s) labeling design and development
-Knowledge in the area(s) of labeling and component materials
-Knowledge of FDA regulations and GxPs
-Knowledgeable of desktop publishing and computer graphics software to execute labeling projects
-Must be able to demonstrate leadership ability
-Must be detail oriented, have the ability to meet deadlines, and have excellent leadership, interpersonal, and communication/influencing/negotiation skills
-Must be a team player and adaptable to a dynamic environment
-Must have the ability to handle highly complex problems and have excellent analytical and investigational skills as well as sound, timely decision-making
-Must be able to handle multiple projects concurrently and have computer experience
-Strong process and project management skills
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.
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.