Shire QC EM/Micro Analyst I (Tues-Sat) in Lexington, Massachusetts
Primary Duties of this position will focus on the daily QC EM/Microbiology lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with supervision.
EM/Microbiology: Area focuses on techniques such as Bioburden, Endotoxin testing, Growth Promotion studies, Environmental Monitoring sampling and testing, Microbial Identifications, Conductivity, TOC, Plate Reading and Biological Indicators,
60%: Testing execution
30%: QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
10%: Compliance and quality systems (SOP revisions, input to quality systems records)
Education & Experience Requirements:
Normally requires a bachelor’s degree and a minimum of 0-2 years related experience.
(Science related degree is preferred)
Other Job Requirements:
Limited to no travel expected.
The following physical abilities are required in order to fulfill the job duties:
Repetitive bending and reaching to setup and break-down equipment
Ability to work around chemicals
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time
Notice to Employment / Recruitment Agents:
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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.