Shire QC Specialist I in Lexington, Massachusetts

Primary Role:

Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to investigation activity, data analysis, data trending, cross functional team support, document revisions, initiating/completing quality systems, identifying CAPA for system improvements, change control ownership, and other activities.

​Specific QC Focus Areas:

Area is focused on environmental monitoring data analysis and reporting, microbiology data trending, microbiology laboratory investigations and CAPAs, LIMS interface, MODA interface, Trackwise interface, and other support systems related to microbiology laboratory.

Technical Support:

Area is focused on various technical investigational and compliance tools in support of the GMP laboratories, EM trending and reporting, EM excursion execution, laboratory deviations, cross functional team membership, and CAPAs related to EM excursions and laboratory deviations.

Responsibilities:

60%:

Data analysis, data trending, data reporting, EM excursion analysis and completion, deviation management

20%:

Regulatory and/or inspection support, initiating/completing quality systems, such as change control or CAPA

20%:

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 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

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.