Specialist, QA Validation

Jubilant Pharma Limited; Spokane (WA); On-site; USD 82,000 - 131,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA / HSA

Life Insurance

AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA seeks a QA Validation Specialist to provide technical expertise through document review and approval, including protocols, acceptance reports, SOPs and specifications. You will support projects as a quality representative across production, engineering, maintenance, IT, and technical services to ensure compliant processes and systems.

You will track validation activities, review transfer protocols, write SOPs, and provide QA SME support for change

Qualifications

• Bachelor of Science or 5 year(s) experience in lieu of degree required.
• 2-5 years related validation experience in FDA regulated industry.
• Pharmaceutical manufacturing, SAP experience, project management desired.
• MS Word, Excel and PowerPoint required.

Responsibilities

• Work with production, engineering, maintenance, IT, and technical services to ensure required documentation is developed to support processes.
• Track and provide technical direction for validation of processes and equipment to ensure compliance with policies and current standards.
• Review product transfer protocols and reports, assess impact to product quality and determine actions.
• Create and write required SOPs pertaining to documentation and QA Validation.
• Review and approve validation protocols, acceptance reports, SOPs and specifications.
• Provide QA SME support for change control and system improvement.

Skills

cGMP knowledge

Education

Bachelor of Science or 5 year(s) experience in lieu of degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Join a Leader in Pharmaceutical Manufacturing - And Build What’s Next

As Spokane’s Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family.

For the Builders, Innovators, and Doers — This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here.

Job Description: Specialist of QA Validation

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 year(s) experience in lieu of degreerequired
• 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.

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

Shift: Monday-Friday

Compensation & Benefits That Start on Day One — Because Your Well Being Matters

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

Unlock Your Potential

If you’re seeking a dynamic and rewarding career, we welcome your application today.

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require assistance applying for a position, contact: [e-mail]

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society