Shire QC Particle Lab Lead in Lexington, Massachusetts
Individual will oversee the day to day operations of the particle lab and partner with internal and external facilities to ensure consistency and on time delivery of particle testing results.
Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination product and material specification management inspection support, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
Will schedule and prioritize particle samples at the Lexington lab facility
Will interface with internal labs and external contract labs to schedule and test particle samples based on sample load and priority
Will perform data review in LIMS and of contract lab reports
Will maintain lab metrics
Will perform document authoring and revisions
Will maintain and update the particle library
Will support other laboratory priorities including new equipment
Will support investigations related to particle identification
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)
Education & Experience Requirements:
Normally requires a bachelor’s degree and a minimum of 0-2 years 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:
-Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
-Ability to work around chemicals (if working around the laboratories)
-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 -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
Individual will work independently and manage in a matrix environment. Successful individual will communicate efficiently and effectively. Individual must be able to handle multiple priorities at the same time.
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.