Stability Associate

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:

Stability Associate: The purpose of this position is to implement required new studies, maintain the stability study program for all products that require such testing, generate related protocols, maintain Standard Operating Procedures (SOPs), and communicate with contract clients as it relates to the stability program. In addition, the Stability Associate will assist in maintaining compliance with the Jubilant HollisterStier Stability Program and provide support in actions required due to power outages and temperature/humidity excursions for stability chambers.

1. Maintain the stability program for the products which require such testing.
2. Ensure that stability batches are provided to the stability department in a timely basis and studies are initiated as required by the appropriate protocol or SOP.
3. As required, enter stability data into the Stability LIMS System and review stability data.
4. Provide required reports as scheduled (Annual Reviews, DMFs, client product reports) or more frequently upon request.
5. Document significant events for stability studies and communicate issues to internal/external stakeholders, as directed.
6. Maintain clear chain of stability sample custody and accurate inventory.
7. Review completed or cancelled studies. Close out studies as required.
8. Revise existing SOPs or create new SOPs as required to document stability department processes.
9. Write study plans, protocols, and deviations, as directed.
10. Research and summarize stability data to assist in resolution of customer complaints, as required.
11. Conduct special projects as directed by the QC Stability Supervisor and/or Manager, such as summarize information on product deviations, failures, or process changes.
12. Work with the QC Stability Supervisor and/or Manager, facilities maintenance, business development, and process development and other personnel to ensure adequate space is available for stability sample storage.
13. Assist with activities to ensure compliance related to Stability areas as directed by the QC Stability Supervisor and/or Manager, including assessment/actions related to chamber temperature/humidity excursions.
14. Assist with stability related Deviation investigations.

Qualifications:

• High School diploma or equivalent plus 2 years of pharmaceutical experience or FDA regulated industry experience is required. Bachelor's Degree, desired.
• No Stability experience required.
• Understanding of cGMP concepts, especially as related to stability studies and quality desired.
• Familiarity with the FDA and ICH guidelines for conducting stability studies desired.
• Basic understanding of various computer programs, which may be used to establish the databases and evaluation methods of the data desired.
• Proficiency in MS Word and Excel required.
• Lifting up to 25 lbs.

Shift: Day Shift

Compensation & Benefits:

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

• Hiring Wage: $27.01 - $36.53/hr. 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