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.
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
Judgment and Decision Making
Energy and Drive
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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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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.