Sr Specialist - QA DI & CSV

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. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

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: Reporting to the QA Data Integrity Supervisor, the Quality Computer Systems Validation (QCSV) Senior Associate will provide Quality unit oversight related to qualification, GxP validation and change management of JHS computer systems. This position will oversee and support Software Validation activities for the Spokane, WA facility. The responsibilities may include the following tasks, knowledge, skills and other characteristics. (This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

• Provide technical expertise to define approaches and execution of computer system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, and other applicable regulations or procedures.
• Work with IT CSV and Engineering to develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and review and approve functionality, usability and testing during required project phases.
• Review and enforce necessary improvements and corrections to established systems and processes via mitigation plans and change control.
• Work with project teams to select methods and techniques for obtaining desirable solutions for each project and ensure compliance with regulations.
• Direct the site Data Integrity program
• Provide QA oversight of CSV Periodic Review program.
• Participate as SME in internal and external vendor audits relating to computerized systems.
• Keep appraised of the developments in all Jubilant Life Sciences' marketplace, and the challenges in the Business Units to identify potential opportunities.

Qualifications:

• Bachelor's Degree in Computer Information Systems, Management Information Systems or related field required.
• Minimum of 5 years related experience in Computer System Validation required (with Bachelor's degree).
• 10+ years of experience can be used in lieu of a Bachelor's degree.
• FDA Regulated Industry experience required.
• Basic exchange of information required. Managing conflict and influencing outcomes required. Must possess excellent communication skills and have the ability to effectively interpret needs and requirements at the business process level as well as at the technical level required.
• Critical problem solving skills required.
• Must possess strong analytical experience and ability to work independently on concurrent assignments required
• Advanced Vocational/Specialized Knowledge required. Microsoft Word, Excel and PowerPoint required.
• SAP, MasterControl, Trackwise, and ComplianceWire desired.
• Supervisory experience desired.
• Pharmaceutical experience desired.
• Other Physical Requirements: Ability to lift 20 pounds unassisted.
• Prolonged sitting.
• Computer use, including keyboard and monitor.
• Ambiguous and complex situations: development of new solutions.
• Minimal travel (<10%) desired.
• Position is minimum 75% on-site
• Subject to broad policy and management guidance regarding business goals.
• Leadership or controlling role on end results.

Location: Spokane, WA - On Site, Hybrid at least 75% onsite

Shift: Monday-Friday 8:00AM-5:00PM

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

Hiring Wage: $89,300.00 - $142,800.00, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

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. Apply online:

Careers - Jubilant HollisterStier

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:
JHS-TalentAcquisition@jubl.com

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