Shire Senior Quality Control Analyst Biochemistry in Social Circle, Georgia

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.

• Conduct critical biological, chemical and physical analyses of in-process and final products to support manufacturing facility production schedules. Perform documentation and review of test data following good documentation practices. Enter final data in LIMS and other computerized systems.

• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner.

• Maintain data integrity and ensure compliance with company SOPs, product specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents.

• Participate in team functions to address production, increase efficiency, solve problems, generate cost savings and improve quality. Perform laboratory and manufacturing audits, as required. Audit and update processes and facility SOPs, as required.

• Perform equipment maintenance and calibrations. Work under minimum supervision. Conduct other duties as assigned.

Requirements:

• Proficiency in both manual methods and instrumentation analyses. Experience performing and analyzing serology and immunology assays.

• Basic knowledge of statistical methods and strong technical problem solving skills.

• Ability to conduct multiple tasks concurrently to meet critical timelines.

• Effective communication skills, ability to train others.

• Proficient use of TrackWise, SoftMax Pro, and MiniTab software a plus.

Qualifications:

• Bachelor’s Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years’ experience, or Master’s Degree in Chemistry, or Biological Sciences, with 0-3 years’ experience.

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.

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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.