$80K — $100K *
Oversees and manages Nkarta’s electronic data management system (EDMS), which is QT9.
· Partners with standard operating procedures (SOPs) authors/owners in functional areas and assists in creating and/or revising documents (SOPs, reports, protocols, specifications, etc.).
· Routes SOPs for review and approval, issue effective SOPs and obsoletes older SOPs; collaborates with other functional areas to establish training applicability for new or revised SOPs. Assigns document numbers.
· Issues and administers logbooks and batch records.
· Leads and maintains Quality training; develops training content; ensures that appropriate staff members are in compliance, either by presenting the material personally or working with outside vendors to provide high quality regulatory compliant material.
· Assists in ensuring Nkarta maintains its compliance with GxP as required. Develops and reports quality metrics to support GxP activities and review.
· Helps select and manage outside vendors related to offsite storage vendors, outside training vendors, and electronic sign off documentation.
· Plays a key role in the Quality Management System QMS implementation plan and supports the QMS roll out.
· Embodies the Nkarta culture of empowerment, diversity, and inclusion.
· Strong MS Office skills (Word, Excel) and general computer skills.
· Advanced understanding of good manufacturing practices (GMP) and ability to apply them to Nkarta’s NK immunotherapy environment.
· Proven ability to work effectively cross functionality.
· Strong verbal and written communication skills to communicate effectively with groups and individuals; ability to initiate as well as respond.
· A competent, effective presenter of training materials.
· Strong analytical skills and an ability to communicate complex issues in a simple way. Able to create plans to resolve issues and mitigate risks.
· Bachelor’s degree; 5+ years in pharma/biotech.
· Prior QA/QC experience including document control experience.
· Previous experience with FDA audits a plus
Valid through: 4/10/2021
$150K — $200K
19 days ago