Shire Senior QC Investigator in Lexington, Massachusetts
Job Summary/Operations Involvement:
Responsible for oversight and execution of complex and critical deviations and investigations related to quality control (QC) out of specification (OOS), out of trend (OOT), and/or process failures within the quality control labs. Responsible for completion of root cause analysis (RCA) as well as identification and generation of corrective and preventative actions stemming from investigation. Organizes, oversees, and performs investigation write-ups within allotted time frames. Works alongside manufacturing, quality assurance, and other applicable departments to ensure that RCA is complete and investigation is completed in a compliant manner. Proactively pursues continuous improvement opportunities related to contamination control, and ensures completion of activities which may decrease likelihood of repeat deviations.
Erroneous decisions can result in critical delays in schedules and / or unit operations and may jeopardize overall business activities.
Contributions are typically limited to individual investigations, CAPAs, or change controls aimed at improving quality control laboratory operations. In some instances, individual will influence and drive change across multiple processes and or departments to increase scope of improvements to across multiple QC laboratories.
The individual will lead or participate in cross functional investigations and represent QC for the department. Must be detail oriented and timeline focused.
70%: Quality Control Investigations and CAPAs
10%: Continuous Improvements in QC
10%: Metrics/performance KPIs
10%: Inspection and regulatory support
Education and Experience Requirements:
Typically requires a minimum of 10+ years of related experience.
Bachelor’s degree in technical or scientific discipline
Additional Specific Experience:
Experience in investigating quality control deviations within the pharmaceutical biologics space.
Experience with analytical assays is required
Experience with QC Microbiology assays is preferred, but not necessary
Familiarity with common analytical instrumentation/software
Experience with regulatory audits
Blue/Green Belt certification is preferred
Other Job Requirements:
Some travel expected; although not routine. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
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:
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Equal Employment Opportunity
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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.