Shire QC Analyst HPLC in Lexington, Massachusetts
Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification has been filed by Shire Human Genetic Therapies Inc. for the following job opportunity:
JOB LOCATION: Lexington, MA
POSITION : QC Analyst HPLC
POSITION DESCRIPTION: Shire Human Genetic Therapies Inc. is seeking a QC Analyst HPLC with the following duties: provide Quality Control operation support, including data review, data trending, and Operational Excellence initiatives; test drug substance and drug product manufacturing, stability, and raw materials; perform protocol studies using test methods derived from compendia and non-compendial sources; ensure Quality Control system compliance, including revising SOP’s; maintain operational GMP readiness for Quality Control; drive complex projects, operational excellence initiatives, and supervise Quality systems; recognize atypical or Out-of-Specification test results, instrument malfunctions and methodology problems, and assist in the investigation to resolve and prevent it; understand and implement 21 CFR Part 211 and ICH regulatory guidelines; engage in HPLC method transfer and validation for protein analysis; work with quality systems and cross-functional teams.
REQUIREMENTS: Bachelor’s degree in Chemistry, Pharmaceutical Manufacturing or related field or foreign academic equivalent plus 4 years related experience OR Master’s degree in Chemistry, Pharmaceutical Manufacturing or related field or foreign academic equivalent plus 2 years related experience. Required skills: recognize atypical or Out-of-Specification test results, instrument malfunctions and methodology problems, and assist in the investigation to resolve and prevent it; understand and implement 21 CFR Part 211 and ICH regulatory guidelines; engage in HPLC method transfer and validation for protein analysis; work with quality systems and cross-functional teams.
Full time. $81,308 – 83,900/year. Competitive compensation and benefits.
Qualified applicants can apply directly to the Shire careers page at: https://jobs.shire.com. Please reference job #R0009312 . EOE
Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Foreign Labor Certification National Processing Center, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, GA 30303.
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.
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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.