Shire QC Specialist II in Lexington, Massachusetts
Data analysis, data trending, project and testing coordination, support of product specification management, COA generation, material specification creation, document revisions.
Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
Involvement in other QC activities as required (ex. records retention)
Primary duties of the position are focused around non-laboratory support of the QC stability functions. Primary activities would generally include but be not limited to:
Enrolling small molecule and biologics lots into stability studies in LIMS at Shire, according to stability protocols. Includes registrational stability studies (Process Validation Runs. PVRs), site-specific stability studies, temperature excursion stability studies, annual enrollment lots and for-cause lots. Enrolling lots into stability studies at contract management organizations according to stability protocols. Writing stability protocols The collection of stability reports, data analysis, data trending/statistical analysis Project management and testing coordination Document revisions (protocols, stability reports and memos) Authoring the stability sections of regulatory filings Completing stability section of annual product quality reports and regulatory updates Initiating/completing quality systems (TrackWise).
Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
Specific QC Focus Areas:
Area is focused managing stability studies, including on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability expertize, an understanding or the ICH stability guidelines is recommended.
Education and Experience Requirements:
Normally requires a bachelor’s degree and a minimum of 2 years of related experience.
(Science related degree is preferred)
Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Conducts work in compliance with cGMPs, safety and regulatory requirements.
Other Job Requirements:
Limited to no travel expected. Travel between sites may be required.
The following physical abilities are required in order to fulfill the job duties:
-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
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.
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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.