Job Description

Target PR Range: 31-41/hr
*Depending on experience

The ideal candidate will have at least 1 year of experience working in a GMP-regulated lab or manufacturing setting, with a strong background in writing and owning quality records such as deviations, CAPAs, and change controls. Experience using the Veeva Quality system is highly desirable. This individual must demonstrate strong communication and grammar skills, a working understanding of QC laboratory processes, and the ability to lead meetings and drive investigations independently. Candidates must be proactive, detail-oriented, and capable of contributing in a fast-paced environment with minimal oversight.

This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

• 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.

Job Tags

Contract work,

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