Operations Specialist
Location:
, Georgia
Posted:
November 17, 2017
Reference:
R0015607
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 Ophthalmic.

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.

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. Shire is a leading global biologics manufacturer opening state of the art facility outside of Atlanta, GA.

The position will support the development of a plasma fractionation facility that will bring Shire additional capacity for fractionating, purification, and fill and finish for its biologic medications. This position will play a key role in:
Lead any CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence
Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
Train staff in general manufacturing activities
Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.

Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
Stay current with biopharmaceutical industry best practices and technologies
Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.

Requirements:
Strong problem solving and analytical skills are required.

Possess knowledge of core manufacturing principles and support systems

Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross functional teams and management on recommended course of action, with minimal assistance.

Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.

Self-driven individual that requires minimal supervision

Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).

Education and/or Experience:
Bachelor of Science degree required (prefer Chemical Engineer, Biological/Biotech Engineer or Biotechnology) with
0-4 years work experience. Professional (GMP industry) experience ideal but not required Working Environment:

May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry)

May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE.

This position may be working on a second or third shift, weekend shift or off-business hours shift. TBD.


A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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