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Summary

Sat Oct 14, 2017 - 5 weeks ago

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Supervisor, Quality Control Operations

Supervises assigned Quality Control Operations staff performing chemistry and biochemistry testing on 2nd shift from Sunday to Wednesday for analysis and reporting of in process, final bulk product and stability samples for the effective operations of a biologics manufacturing facility.



+ Develops and manages staff schedules to meet workflow demands


+ Develops and implements standard methods and procedures for technical transfer of methods, inspection, testing, analysis of data and trends, investigations, staff training, and equipment maintenance and calibration.


+ Ensures cGMP compliance in all aspects of QC Operations laboratories.


+ Recruits and develops a high performing team with diverse backgrounds and talents.


+ Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.


+ Maintains and communicates performance metrics for her/his team, setting and maintaining high expectations for team performance.


+ Provides technical leadership to QC Operations, serves as Subject Matter Expert in cross functional, cross departmental work teams and participates in the site team supporting and managing regulatory inspections and findings.


+ Investigates out-of-specification results and writes or supervises the writing of investigation reports.





Qualifications:



+ BS/BA in science - Microbiology, biology, chemistry, biochemistry or a related discipline - or its equivalent is required.


+ A minimum of 6 years experience in quality control.


+ Experience in overseeing QC testing is preferred.


+ A minimum of 3 years of supervisory experience preferred.


+ Strong background in chemistry/biochemistry methods for biologics methodology.


+ Extensive knowledge of US and EU cGMP regulations USP, regulatory requirements and industry best practices.


+ Demonstrated leadership, interpersonal, communication, motivation skills with strong problem solving and analytical thinking skills.


+ Knowledge of applicable business systems including: LIMS, SmartLab, Trackwise and Investigates out-of-specification results and writes investigation reports.


+ Experience with regulatory agency (FDA, EMEA, TGA) inspections preferred.



We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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