Shire Operations Specialist II (CAPA Investigator) in Social Circle, Georgia

Description:

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.

The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Baxter additional capacity for fractionating, purification, and fill and finish for its biologic medications. This position will play a key role in start-up operations supporting manufacturing in areas like documents authoring, deviations investigation and CAPA determination and change controls implementation

Essential Duties and Responsibilities:

Drive manufacturing deliverables to ensure successful commercial operations, including:

  • Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:

  • Lead problem solving and root-cause analysis sessions

  • Interact with Quality, Engineering and Tech Service units

  • Manage complex investigations using DMAIC tools

  • Ensure effective implementation of corrective and preventive actions

  • 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.

Qualifications:

  • Must have a general understanding of the business and strategic plan.

  • 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), Trackwise.

  • Prefer proficiency in Automation Control Systems, EBM (Electronic batch Record), PI Historian

  • Prefer knowledge of Lean Six-Sigma methodology

Education and/or Experience:

Bachelor of Science degree required (prefer Chemical Engineer, Biological/Biotech Engineer or Biotechnology)

Minimum five years relevant professional (GMP industry) experience required

Demonstrated ability to perform in a high performing workforce

Working Environment:

  • This is a green site so first few years of project employees will be working on the construction site in temporary office space.

  • 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.

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

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.

EEO is the Law at http://baxalta.com/assets/documents/eeocselfprint_poster.pdf

EEO is the law - Supplement at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy at http://www.dol.gov/ofccp/pdf/EO13665PrescribedNondiscriminationPostingLanguageJRFQA508c.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.

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.