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Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Follow applicable departmental Standard Operating Procedures and Work Instructions.
- Complete required trainings according to required timelines.
- Administer controlled documents ensuring availability to the end user.
- Track and report metrics as determined by management according to required timelines.
- Assist with implementation of new/revised processes and procedures.
- Demonstrated ability to communicate effectively.
- Perform checks to ensure quality of work completed.
- Ensure timely escalation and resolution management of issues impacting controlled document release.
- Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
- All other duties as needed or assigned.
Requirements
What you’ll need- A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
- 4 to 6 years in regulatory environment (experience in GXP roles).
- Strong knowledge of QMS, CAPA management, and Veeva Vault.
- Experience in audit processes is an added advantage.
- Strong interpersonal skills with ability to work well with others.
- Demonstrated ability to plan, prioritize, organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Strong analytical skills.
- Ability to deliver consistent high quality of work.
- Ability to use computer and departmental tools.
Benefits
Comp & perks- Health insurance
- 401(k) matching
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory ComplianceQuality AssuranceQMSCAPA managementVeeva VaultAudit processesMetrics trackingDocument administrationProcess implementationAttention to detail
Soft Skills
Effective communicationInterpersonal skillsPlanningPrioritizationOrganizationAnalytical skillsProblem resolutionTeam collaborationQuality focusAdaptability
