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Document Control Specialist, Quality Systems
Foster City
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.
POSITION SUMMARY
Document Control Specialist, Quality Systems assists with Mirum’s Document Control program, supporting Veeva QualitySuite systems. This includes continuous improvement and delivery of training materials for the quality management electronic systems. The specialist will be responsible for ensuring completion of process-related administrative functions. This role will provide ongoing support for the Document Control, training and eQMS teams.
JOB FUNCTION/RESPONSIBILITES:
- Support the Document Control team in the administration and maintenance of the electronic document management system (EDMS).
- Help drive continuous improvement activities to adapt to business and company needs.
- Support the Business Process Owner for regulated DocuSign.
- Assist with Document migration activities.
- Assist with review of new and revised procedural and business documents.
- Facilitate the periodic review of controlled documents.
- Assist with development and management of documentation system KPIs, metrics, and proactive issue identification and resolution.
- Provide day-to-day EDMS assistance and troubleshooting for existing users.
- Create training material, and training videos, for the EDMS and eQMS.
- Perform system training for new hire employees and contractors for the EDMS and eQMS to ensure personnel are appropriately trained to carry out their responsibilities.
- Provide support during audits and Regulatory Health Authority inspections.
- Act as the company’s Archivist, supporting and managing day-to-day archival activities.
- Coordinate off-site scanning, storage services and maintain associated document lists.
- Support system enhancement initiatives.
- Perform other duties as assigned by Manager.
QUALIFICATIONS:
Education/Experience:
- Bachelor’s Degree.
- 3+ years of experience in the pharmaceutical industry within Quality Assurance role.
Knowledge, Skills and Abilities:
- Knowledge of maintenance of a compliant Document Control program.
- 2+ years of experience EDMS support.
- Previous experience with use and administration of Veeva QualityDocs and/or eQMS required.
- Experience with ComplianceWire eLMS preferred.
- Familiarity with 21 CFR Part 11, the GxPs, computerized system validation and experience working in a regulated environment.
- Knowledge of Good Documentation Practices and ALCOA+ principles.
- Archival experience.
- Strong verbal and written communication skills.
- Proficiency in Microsoft Office Suite including Excel, PowerPoint, Word and Outlook is required.
#LI-Onsite
Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.
