Specialist, QA Validation

Jubilant Hollister Stier Spokane is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Specialist of QA Validation 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.
• Review product transfer protocols and reports, assess impact to product quality and determine appropriate actions.
• 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’ experience in lieu of a degree.
• 2‑5 years of related validation experience in FDA‑regulated industry such as pharmaceutical, medical device, or food manufacturing. Minimum 2 years required.
• Proficiency in Microsoft Word, Excel and PowerPoint.
• In‑depth understanding of cGMP requirements, European regulatory requirements, relevant USP chapters, and scientific principles associated with the manufacture of sterile products and the testing of those products.
• Ability to provide QA SME support for change control, system improvement, risk assessments, and business development projects.

Location: Spokane, WA — On Site, Full‑Time

Shift: Monday‑Friday

Compensation & Benefits: Hiring Wage: $81,800.00 – $, with opportunities for growth, promotion, and annual raises.

Starting on your first day, you receive:

• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short‑Term & Long‑Term Disability Insurance
• Employee Assistance Program

Jubilant Hollister Stier is an EEO/AA Employer.