QA Validation Specialist

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

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 and client support as a quality representative. Essential responsibilities include but are not limited to:

1. 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.
2. 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.
3. Review product transfer protocols and reports, assess impact to product quality and determine appropriate actions.
4. Create, and write required SOPs pertaining to documentation and QA Validation.
5. Review and approve validation protocols, acceptance reports, SOPs and specifications.
6. Recognize compliance issues that may occur and provide QA SME support for change control and system improvement.

Qualifications:

• Bachelors of Science Degree in a scientific discipline or 5 years of experience in lieu of degree required.
• 2-5 years of related experience required.
• Minimum of 2 years qualification/validation experience.
• Must have 3 years' pharmaceutical experience.
• FDA regulated industry experience required.
• Proficiency in Microsoft Word, Excel and PowerPoint required.
• This position requires an 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
• Physical Requirements: Ability to lift 20 lbs unassisted and prolong sitting.

Shift: Day

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: $67,725 - $101,200 annually depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.

Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off plan
• Employee Assistance Program

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All 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.

If you require assistance applying for a position, please contact our HR Department at:

Human.Resources@jubl.com