Specialist QA Validation/ Sr. Specialist, QA Validation

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

Reporting to the Supervisor of QA Validation, the Specialist of QA Validation/ Senior 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 Senior Specialist will provide project / client support as a quality representative.

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:

• Bachelor of Science or 5 year(s) experience in lieu of degree required
• 2-5 years related validation experience in FDA regulated industry, such as pharmaceutical, medical device, or food manufacturing. Minimum 2-years required
• Pharmaceutical manufacturing, SAP experience, project management desired
• Working Knowledge in 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

Sr. Specialist of QA Validation (In addition to the above):

• 5-10 years related validation experience in FDA regulated industry, such as pharmaceutical, medical device, or food manufacturing. Minimum 3-years in pharmaceutical required

Shift: Weekday Days, Monday-Friday

Compensation & Benefits:

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

• Hiring Wage:
  • Specialist of QA Validation: $77,968.80-$101,200 annually depending on experience, with opportunity for growth, promotion and annual raises 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
  • Sr. Specialist of QA Validation: $77,968.80 - $113,900 annually depending on experience, with opportunity for growth, promotion and annual raises. 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

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:

JHS-TalentAcquisition@jubl.com