Shire Quality Control Analyst 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.

Perform calibration and preventative maintenance activities on a wide range of QC instruments and equipment.

Understand and assist with documentation in a variety of computerized systems, including JDE/RAM/LIMS.

Assist with the installation and validation of sophisticated laboratory instrumentation and computer systems to collect and record data, as needed.

Perform lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities. Work under minimum supervision.

Complete all testing, including special project / protocol testing in a timely and appropriate manner.

Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

Investigate deviations and write exception documents.

Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

Ability to multi-task and set priorities for multiple projects. Ability to deliver high quality results within set timelines.

Must communicate effectively (verbal and written) with supervisors and peers and be able to work cross-functionally with other groups.

Must demonstrate effectiveness in ability to train others.

Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

Knowledge of chemical and biological safety procedures.

Strong computer skills, knowledge of Microsoft Word, Excel and PowerPoint.

Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry or Microbiology Laboratory coursework and 0-2 years’ experience

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.