Shire QA Specialist II in Cambridge, Massachusetts

P r i m a ry D ut i es

Routine management & coordination of GMP compliance systems and policies for Alewife facility. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Review of production records for compliance on and off the production floor, as well as other tasks that is the floor groups responsibility. Initiation, review and approval of deviations initiated during production and manage other quality systems as trained and required. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised and continuous improvement championed and implemented. Accountable for meeting functional area goals and objectives as they relate to departmental and HGT goals. Responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.

*Must be able to work occasional Weekends in rotation

R e s p o n s ibi l i t ies

50 % Record reviews and on / off floor tasks

45 % Quality System management

5% Continuous Improvement

E d u c a tion a n d E x p e r i e n c e R e q u ir e ments

  • A minimum of a B.S. degree in science or engineering with at least 3

years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.

  • Excellent interpersonal skills and the ability to communicate well orally and in writing.

K e y S ki l ls, A bi l itie s , a n d C o mpeten c ies

  • Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.

  • Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises.

  • Ability to work effectively in a fast-paced environment

  • Strong written and oral communication skills required

  • Good interpersonal skills required

  • Adherence to domestic and international GMP regulations, cGMP’s, company policies and DNA leadership capabilities.

  • Teamwork skills essential

  • Strong organizational skills

  • Ability to multi-task in a dynamic environment with changing priorities

  • Strong work ethic

  • Ability to meet challenging timelines, in spite of obstacles.

  • Flexible

C omplex i ty a n d Pro b l e m S ol v ing

Contacts are primarily with other professionals in the group (quality), manufacturing, facilities and investigations.

Intern a l a n d E xt e rnal C o n ta c ts

Employee at this level is involved in a variety of tasks of low to moderate level

scope and complexity.

Candidate receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy.

Responsible for implementing global QA approaches based on sound principles, international industry/regulatory standards, and robust scientific basis. Responsible for troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions.

Oth e r J o b R e q uir e men t s

Must be flexible to work late shifts and weekends on ad-hoc basis.

Key Leadership Capabilities: proficiency/excellence in all Job Scope 2 capabilities

  • Accountability & Ownership

  • Delivering Excellence

  • Self-Knowledge

  • Judgment and Decision Making

  • Energy and Drive

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, 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.