Tech II, QA Rec Retention

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: The QA Records Retention Technician is part of a team that receives, retains, and securely houses site-wide documentation and maintains order and accountability for retention sample vials in designated areas throughout the facility. They will communicate extensively with and support all departments in the facility in locating a variety of records needed for review, correction, or reference in a timely manner. Additionally, the Associate is responsible for the tracking and management of all off-site records. Executes multiple system administrative functions in various digital databases. Support all Regulatory and Client Audits and maintain a controlled access area for facility records. Essential responsibilities include but are not limited to:

1. Intermediate, competent in all job functions and can work independently with minimal guidance.

2. Maintain and perform administrative functions in various Records database types, i.e. LUMAC Database,

Access Database, Librarika Database etc. Accurate and consistent maintenance of these digital systems are

crucial to document retention and accountability, support for Client and Regulatory audits, support for

Compliance investigations, and high-volume review requests.

3. Receive, account for, digitally/physically locate, and systematically house Manufacturing controlled

documents, Quality documents, and facility records in a controlled access area in accordance with

established format determined by record type on a daily basis.

4. Coordinate the transport of records between the main facility and third party off-site storage partner; adhere

to department SOPs for the checkout/reprocessing/refiling of specific document types requested via

appropriate Records digital database systems.

5. Account for and manage voided controlled paperwork i.e. machinabilities, demos, media fills, production

records, HEPA, maintenance, and EM compliance logs.

6. High volume issuance and retention of facility LUMACS, logging appropriately in database to maintain

traceability and prevent duplicate issuance. Conduct yearly LUMAC review.

7. Scan all CMO batch records for QA Release department with an organized and methodical approach,

ensuring they meet standards for Release/Client Review. Prioritize batches deemed critical due to client

request and for incident investigation and closure.

8. Follow department procedures for the destruction of records and retention samples both on and off site, in

accordance with established retention periods and in coordination with Project Management to ensure

proper approvals are obtained.

9. Maintain retention sample areas that adhere to the proper storage conditions; receive and process daily,

monthly and annual requests for sample review. Maintain retention sample warehouse movement

transactions in SAP database.

10. Coordinate and effectively communicate with QA Compliance to review and process client complaints and pull appropriate APRs for Annual Product Review.

11. Support Manufacturing with document requests to drive timely closure of Investigations, PRs, CAPAs and Change Controls.

12. Coordinate and effectively communicate with the QA Document Systems Manager in support of client and regulatory audits, providing requested documents quickly and efficiently.

13. Manage Quality shred bins for the weekly destruction of discarded documents via contracted third party.

14. Initiate, revise and serve as collaborators on department SOPs as needed.

15. Provide investigation support and RCA (Root Cause Analysis) input for deviations and CAPA events.

16. Position requires occasional call-in off shift to support client and regulatory audits.

Qualifications:

• High School Diploma or Equivalent required.
• Associates of Arts or Science preferred.
• 2-3 years related experience required.
• Must possess excellent computer skills required.
• Must have proficiency with MS Word, Excel required.
• FDA Regulated Industry Experience preferred.
• Must possess excellent computer skills and understanding of computer technology in order to input information into various programs required.
• Microsoft Word and Excel required.
• Adobe Acrobat knowledge required.
• Proficiency in spelling, punctuation, and grammar are desired.
• Basic exchange of information.
• Managing conflict and influencing outcomes desired.
• The incumbent must establish priorities for multiple tasks and be flexible to changing priorities on short notice.
• The incumbent must be able to resolve minor discrepancies in SOP documentation directly with the initiator or department supervisor.
• Other Physical requirements:

• Prolonged sitting the incumbent will spend approximately 90% of the time in this position working at a computer.
• Ability to lift 60lbs unassisted

• The incumbent will deal directly with all departments to assist in the storage and retrieval of records.

• Routine environment with simple rules and detailed instructions.
• Repetitive/patterned situations: choices of learned solutions.
• Differing situations: search for solutions or new applications desired.
• Minimal travel (<10%) desired.
• Subject to detailed instructions / established routines.
• Subject to practices/well-defined policy, management reviews result after the fact.
• Routine support which does not have a measurable effect on workflow. Provides analysis, diagnosis or production tasks which noticeably impact end results desired.
• The incumbent will be allowed to resolve minor issues directly with the affected departments or personnel. Major issues will be brought to the attention of the department supervisor.

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

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

Hiring Wage: $25.12- $33.97 TO INCLUDE SPECIFIC SHIFT DIFFERENTIAL, 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.