Sr. Quality Assurance Specialist - Manufacturing Support
: $94,360.00 - $141,170.00 /year *
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uniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible for improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.
Place in the Organization
The Senior Quality Assurance Specialist supports the day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training in support of biologics manufacturing production.
Key result areas (major duties, accountabilities and responsibilities):
Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs. Review and approve batch records. Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities. Review and approve preventative maintenance, calibration, and work order documentation. Support internal and external audits. Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release. Review, assist in the investigation of, and approve environmental excursions. Provide on-the-floor QA support for manufacturing activities. Represent Quality Assurance on project teams and in meetings. Support the continuous improvement and oversight of Quality Management System procedures.
A minimum of a Bachelor s degree in Life Sciences or Engineering 6-8 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment Experience working in a GMP manufacturing environment Well versed in cGMP/ICH/FDA/EU regulations and guidelines Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint) Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically
Strong communication skills Strong organizational skill Capable of working with minimal supervision Ability to work well with diverse groups Ability to manage multiple activities with challenging timelines Associated topics: biochemistry, biomedical, biophysics, enzyme, fermentation, genetic, medical, neuroscience, nutrition, therapeutic