Shire QC Analyst I in Lexington, Massachusetts

Primary Role

This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.

In this role, the primary responsibility for the individual in this position is to perform routine analytical testing on raw materials as, using methods derived from a broad range of compendial and non-compendial analytical techniques as well as peer review of test data.

In addition, the individual may be assigned complex projects such as instrument qualification, method validations and continuous improvement initiatives with some supervision. This position is also expected to work with QA and area management on quality systems such as deviations, Change Controls, CAPAs and OOS investigations, to achieve timely closure and ensure compliance.

Responsibilities

  • 45%: Testing of Raw Materials per compendial and non-compendial methods for cGMP manufacturing use.

  • 15%: Peer review /approval of test data.

  • 15%: Author/manage planned and unplanned deviations, Investigations, Change Controls, CAPAs, and OOS investigations

  • 15%: Project management – new instrument/equipment implementation, SOP creation/revision, validation protocol generation/execution, operational excellence/continuous improvement projects.

  • 10%: Support warehouse operations (may include inspection, labeling, and sampling as required).

Education & Experience Requirements

BS in Chemistry/Biochemistry/Biology with 2 to 4 years of relevant experience

Other Job Requirements

Travel between sites is required. Weekend and off hours work may be required.

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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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.