Shire QC Specialist - Technical Writer in Lexington, Massachusetts
Primary role is to provide technical writing expertise by functioning as the QC SME on the documentation management system; facilitating document creation, revision, and obsoletion; managing document review cycles with QC staff; and archiving quality records. Additional support for generation of certificates of analysis, data trending and metrics, and forecasting is a secondary aspect of this position.
Technical writing and support in the document management system (material specifications, lab documents).
Data analysis, data trending, COA generation.
Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
Education & Experience Requirements:
Normally requires a bachelor’s degree and a minimum of 0-2 years’ experience in a GMP environment.
(Science related degree is preferred)
Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Ability to work well with modest oversight and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.
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
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.