Laboratory Validation Specialist
Astrix · Rensselaer, NY · 2 wk ago
Quality Assurance$55–$78/hrFull-time
Location: Rensselaer, NY
Pay: $55–$78/hr (DOE)
Type: Contract (Potential Extension/Conversion)
Responsibilities
- Provide quality review and approval of validation activities related to equipment, systems, and process changes
- Develop, execute, and review IQ, OQ, and PQ validation protocols and reports
- Review and approve validation documentation, change controls, and deviation investigations
- Support root cause analysis and non-conformance resolution
- Ensure validated state of equipment through documentation and compliance review
- Support audits, inspections, and regulatory readiness activities
- Partner with QA, Engineering, and R&D on validation strategy and execution
- Maintain accurate validation records and support Annual Product Reviews (APR)
Requirements
- 6+ years of validation, QA, or pharmaceutical/biotech manufacturing experience
- Strong experience with IQ/OQ/PQ and GMP environments
- Background in lab equipment validation and/or API manufacturing preferred
- Experience with change control, deviations, and audits
- Strong understanding of cGMP and FDA requirements
- Strong documentation and communication skills
Skills
- Experience in API or small molecule manufacturing (nice to have)
- Familiarity with LIMS, TrackWise, or similar quality systems (nice to have)
This job description lists desired skills, but not all are required. We encourage candidates with some of these skills to apply.