Specialist, QA Validation

Job Description

The QA Validation Specialist will provide technical expertise via review and approval of documents including but not limited to Protocols, Acceptance Reports, SOPs and Specifications. The QA Validation Specialist will provide project / client support as a quality representative.

Work with the production, engineering, maintenance, IT, and technical services departments to assure that all required prerequisite documentation is appropriately developed to support process, cleaning, facilities, aseptic, and filling/packaging activities.

Track and provide technical direction for new and continued validation of processes and equipment to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.

Create, and write required SOPs pertaining to documentation and QA Validation.

Review and approve validation protocols, acceptance reports, SOPs and specifications.

Recognize compliance issues that may occur and provide QA SME support for change control and system improvement.

Qualifications

• Bachelor of Science or 5 years of experience in lieu of degree required
• 2-5 years related validation experience in FDA regulated industry, such as pharmaceutical, medical device, or food manufacturing required
• Minimum 2-years required
• Pharmaceutical manufacturing, SAP experience, project management desired
• Microsoft Word, Excel and PowerPoint required
• In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with manufacture of sterile products, testing required on those products, and relationship of quality principles with manufacturing and testing required.
• Must be able to provide QA SME support for change control, system improvement, risk assessments, and business development projects required.

Benefits

• Hiring Wage: $81,800.00 – $130,900.00, with opportunities for growth, promotion, and annual raises.
• Starting on your first day, you receive: Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Location

Spokane, WA — On Site, Full-Time Shift: Monday-Friday

Compensation & Benefits

Because Your Well Being Matters