This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the NC facility.Responsibilities:
Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
Individual will lead investigation teams and help to collect and report metrics for the systems team
Individual may assist with review of validation documents to support equipment and computerized system onboarding.
Individual may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
Support the startup of a GMP QC laboratory.
Support routine activities over the weekends and public holidays as required.
Requirements / Qualifications:
High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors
Deviation and Change control writing experience
Veeva system experience
Leadership capabilities - must be able to lead meetings, drive investigations.
Hiring manager is focused on practical aptitude and writing skills.
