Specialist II, QA (Quality Systems / Trackwise)
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Supports the development, maintenance and training of quality procedures, and systems related to Change Controls, Deviations, Corrective and Preventative Actions, Adverse Events and Pharmaceutical Technical Complaints. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Policy requirements.
* Ensures that all aspects of USFCC operations comply with the requirements of the Seqirus Quality Policy and meets all relevant cGMP regulatory requirements
* Supports the development and continuous improvement of quality systems for Change Controls, Deviations, Corrective and Preventative Actions, Adverse Events and Pharmaceutical Technical Complaints
* Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility
* Provides training for the site on each quality system including system roll out, use and maintenance
* Works collaboratively across the various functional areas to ensure understanding of the systems and consistent execution
* Leads the implementation and use of the Trackwise computerized systems to support the quality systems group
* Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site
* Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams
* Hands on field execution and data collection, and assist with analysis and review of data
* Bachelor s degree in Science / Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
* Bachelors and 3+ years experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry or equivalent.
* Sterile product manufacturing knowledge preferred. Biopharmaceutical experience a plus.
* Experience in the development, maintenance and training in Quality Systems related to Change Controls, Deviations, Corrective and Preventative Actions, Adverse Events and Pharmaceutical Technical Complaints.
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.