QA Validation Specialist 3

Responsibilities

• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment.
• Drive/own the validation plans and execution of equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
• Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
• Develop validation protocols from plans and engineering documents.
• Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
• Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviations, CAPA).
• Perform other duties as assigned.

Qualifications

• Experience with Kneat is absolutely required.
• Experience with Ellab for Temp Mapping is a plus.
• Manager is looking for candidates with Cleaning Val (CIP, COP, SIP).
• 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media Hold/Media Fill.
• Cleaning Val is mostly Drafting SOPs.
• Other equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient).
• Build Equipment Requalification's in Kneat.

Skills

• SOP Development
• Corrective and Preventive Actions (CAPA)
• Quality Assurance (QA)
• Quality Control (QC)

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term disability
• 401K plan

Pay

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including:

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term disability
• A 401K plan (all benefits are based on eligibility).

Company Information

This posting is open for thirty (30) days.