Overview
On Site
Full Time
Skills
Editing
Risk Assessment
UI
Testing
Test Scripts
URS
IQ
OQ
PQ
QMS
Microsoft Office
Conflict Resolution
Problem Solving
Critical Thinking
Management
Attention To Detail
GMP
Documentation
Mentorship
Job Details
Responsibilities:
- uthoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
- Running test scripts and documenting results.
- dherence with project schedule for all assigned activities.
- Maintaining clear, detailed records qualification and validation.
- Documenting impact and risk assessments as part of a team.
- Completing user interface testing, software verification, and complete alarm testing on automated systems.
- Developing, reviewing, and executing testing documentation.
- Making recommendations for design or process modification based on test results when executing test scripts.
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ
- Must be willing to work onsite in Bloomington, IN.
- Bachelor's Degree or equivalent required.
- 3+ years' experience in leading CQV activities specific to Process Equipment.
- Fill/Finish experience preferred.
- Experience with Track wise/QMS software.
- Proficiency using PC and Microsoft Office tools.
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
- bility to work as part of a team and independently.
- Strong problem-solving and critical thinking skills.
- Excellent organizational and time management skills.
- Strong attention to detail.
- GMP and Good Documentation Practice.
- Capable of working on assigned tasks without mentorship.
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