At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Shire QC Scientist (f/m) in Lange Allee 24 (Baxalta), United States
Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method (release, IPC, stability, process qualification / process monitoring) implementation and maintenance
Manage activities to support key projects (e.g. assay transfers)
Plan ICH conform method validations / qualifications
Write protocols and reports for method validations / qualifications, method transfer and comparability studies as well as qualification documents for standards and reagents, and implementation of assay controls
Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
Lead and drive analytical assay investigations (OOS, CAPA, etc)
Knowledge sharing of problems that were found and share solutions to drive continuous improvement
Create and review submission documents
Plan and document change requests related to analysis methods
Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
Expertise with analytical methods (HPLC/GC, wet-chemistry tests, photometric tests, enzymatic/biochemical tests)
Knowledge of analytical method validation and critical reagent qualification
Experience in problem solving (facilitation and application of tools)
Statistical knowledge and experience with data analysis
Knowledge of regulatory requirements concerning analytical test methods (EP/USP)
Six Sigma Greenbelt training would be beneficial but is not required
Fluency in German and English (sufficient for international teleconference calls)
Technical writing skills in English and German
Target-oriented teamplayer, problem solving skills
Position is limited until June 30, 2020
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria. at https://youtu.be/ly_8oO-iJeU
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.
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.
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.