Shire Quality Assurance Specialist II in Social Circle, Georgia
Conduct biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods. Write and execute validations for manufacturing processes and laboratory instruments and methods.
Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at Baxter manufacturing facility.
Write and execute validations for manufacturing processes and laboratory instruments and methods.
May serve as mentor to other Quality Laboratory positions. Provide training and work direction for Quality Laboratory Associate II positions as required. Manage work flow and laboratory release functions in specified laboratory areas and on off shifts.
Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
Work on special projects / protocol testing that involves new methods and instrumentation Complete all testing, including special project / protocol testing in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents.
Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.
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.