Quality Assurance Specialist
KellyOCG · Red Lion, PA · Yesterday
On-siteConsulting$41/hrContract
Location: Red Lion Road, PA
Duration: 12 months
Pay: $41 per hour
About the role
As part of the GETUP training enhancement initiative, this Quality Assurance Specialist will author and/or revise Standard Operating Procedures (SOPs), Work Instructions (WIs), Guidance Documents (GUID), and similar GMP Quality documents used in the Site Training Program for Quality Roles. Additional work could include support activities for the quality documentation management at the Site (i.e. archival, document issuance, etc.) or Site Training support and organization (i.e. learning plan enhancement for Quality Roles, updates to learning management system, etc.).
Responsibilities
- Authors Quality SOPs, WIs, etc. in alignment with the GETUP Program
- Supports digitization of quality trainings in the learning management system
- Coordinates and supports project work to enhance quality training program
- Administratively supports the design, development and delivery of quality training programs
- Administratively supports quality training document review and other quality processes, as needed
Requirements
- At least 2 years of experience in a GMP environment
- Experience in authoring GMP documents such as SOPs
- Experience with Good Documentation Practices (GDP)
- Intermediate proficiency in Microsoft Office Suite (Primarily Teams, Word, Excel, and PowerPoint)
- Highly organized
- Strong detail orientation
- Strong critical thinking
Qualifications
- Bachelors Degree required
Skills
Desirable:
- Experience with Veeva Vault
- Experience supporting the Quality Assurance/ Quality Assurance documentation or procedure authoring teams in a GMP manufacturing or pharmaceutical organization
- Experience working in Learning Management Systems (Cornerstone/SABA strongly preferred)
- Experience with data processing