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Quality Lab Associate III

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
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.
Job Function and Description
+ Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).
+ Conduct biological, chemical and physical analyses on raw materials, in-process and final containers or other samples collected from the Shire Georgia manufacturing facility.
+ May serve as mentor to other Laboratory positions. Provide training and work direction for Laboratory Associates positions as required. Manage work flow and laboratory release functions as specified by leadership.
+ Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems as needed.
+ Use sophisticated laboratory instrumentation such as UPLC/MS, ICP/MS, GC 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 and cGMP regulations. Conduct Laboratory investigations as directed by Lab leadership.
+ Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
+ Perform laboratory audits as required. Audit and update, as required, SOPs.
+ Ensure employees are properly trained and/or qualified and periodically audited. Ensure personal training requirements are met and that training records are current.
+ Perform routine walk-throughs and compliance checks to verify adherence to quality guidelines and appropriate laboratory technique.
+ Monitor testing techniques of laboratory personnel and review accuracy of records and documentation generated.
+ Assist in assay and equipment trouble shooting and ensure equipment maintenance and calibration is robust and completed on time.
+ Lead and/or support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams.
+ Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
+ Other duties, tasks or projects as assigned.
Education and Experience Requirements
+ Typically requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience.
Key Skills, Abilities, and Competencies
+ Strong interpersonal skills and great attention to detail are necessary.
+ Must be a strong team player with good problem solving, and good verbal and written communication skills.
+ Must have the ability to manage people, encourage teamwork and drive decisions.
+ Must be able to handle multiple projects concurrently.
+ Must have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
_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, gender identity, 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/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Reasonable Accommodations
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.


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