Shire Manufacturing Compliance Investigator I 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 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.

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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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.