QA Compliance Associate-Weekdays

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:

The QA Compliance Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities.

1. Lead, facilitate, and conduct deviations, non-conformances investigations.
2. Author/draft investigation reports with minimal guidance.
3. Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
4. Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.
5. Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP.
6. Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance.
7. Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors.
8. Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.
9. Work with cross functional team member(s) to develop appropriate CAPA actions.
10. Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
11. Act as liaison as it relates to specific investigations during client calls and audits.
12. Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms.
13. Communicate/Escalate to management any issues or delays identified during the investigation process.

Qualifications:

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in a lieu of an Associate's degree required
• Bachelor's Degree in a science field desired.
• Sologic Certificate desired
• Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
• Pharmaceutical and FDA regulated industry experience desired.
• Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Working knowledge in Microsoft Word & Excel required.
• Knowledge of cGMPs desired.

Shift: Weekday Days, Monday - Friday

Compensation & Benefits:

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

• Hiring Wage: $30.99 - $41.93 hr. 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