Shire Senior QA Operations Specialist in Lexington, Massachusetts
This individual is responsible for providing senior level support for issues of moderate complexity at a minimum. Routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities for bulk drug substance disposition. 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. Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices and optimal utilization of staff. Review of production records for compliance. Assures cGMP’s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and company-wise goals. Responsible for adhering to GMP regulations, cGMP’s, company policies, and leadership capabilities.
Support of customer group quality systems
Develop and aid in development of solutions for moderate to complex problems
Work on moderate to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results
Network with key contacts outside own area of expertise
Contribute to the development of new concepts, techniques, and standards
Work independently without appreciable direction
Exercise latitude in determining objectives and approaches to assignments
Serve as special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives
Ensuring that practices are consistent with quality and regulatory standards
Providing support during regulatory agency site inspections
Support an environment of teamwork and collaboration
Project and improvement initiative participation
Education and Experience Requirements:
Essential: A minimum of a B.S. degree in science or engineering with at least 3-5 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments.
Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Desired: Direct Biologic Pharmaceuticals experience within Technical Operations
Must be flexible to work late shifts and weekends on ad-hoc basis, but not common. Would be required for Regulatory inspections and/or critical quality systems
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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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.