Shire Senior QC Systems Analyst II in Lexington, Massachusetts

Primary Role:

Job Summary/Operations Involvement:

Sr. QC Systems Analyst 2

In this role, the individual will provide hands-on end user support, administration, installation and issue resolution for GMP laboratory equipment, desktops and software packages with a focus on application functionality and interoperability within the Shire environment. Perform upgrades to ensure ongoing data integrity and business continuity/sustainability of lab systems (software, desktop components, peripherals, etc.), create system documentation and author/execute test scripts as needed in support of AIQ and CSV activities. In addition, the role provides support for periodic review of lab systems and audit trails, as well as data integrity assessments and mitigation.

Discretion/Latitude:

Erroneous decisions will result in critical delays in schedules and / or unit operations and may jeopardize overall business activities.

Impact:

Exerts influence in the development of overall objectives and long-range goals of the organization. Erroneous decisions or recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity.

Responsibilities:

30%:

Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.

20%:

Perform laboratory equipment, hardware and software upgrades following corporate computer system validation policy and GMP best practices.

10%:

Coordinate with users and vendors to facilitate timely resolution of software / hardware issues.

10%:

Execute routine system administration and maintenance activities as required, including system reviews and audit trail reviews.

10%:

Create and/or execute software validation scripts to support laboratory.

10%:

Create and maintain system documentation including system design specifications, user requirements, functional requirements or routine controlled application change forms.

10%:

Proactively communicate with laboratory stakeholders and update helpdesk tracking software as necessary.

Education and Experience Requirements:

Minimum requirements include a Bachelor's degree in computer science, information technology (or equivalent) and 6 to 9+ years pharmaceutical/biopharmaceutical laboratory industry experience. Qualified candidate must have demonstrated knowledge of server / application administration, laboratory equipment, network concepts, and GMP validation best practices. Experience with Citrix administration, database administration, application development / scripting is a plus.

Other Requirements:

Periodic travel may be required for business meetings with company peers, vendors/contractors, and for staying current with professional development. Routine local travel to Mass Biologics Operations sites.

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.