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.

This position is located in Spokane, WA and relocation assistance provided.

Job Description:

The Supervisor I-II, QA Compliance and Oversight provides support to the Manager of QA Compliance and Oversight. The Compliance and Oversight teams execute site quality systems which investigation of unexpected events, root cause analysis, and corrective actions. The team also provides oversight over GMP operations within all departments onsite by monitoring activities and reporting and responding to risks. This position provides direction and support of the daily operations in the QA Department through scheduling, and assignment of tasks as well as the performance management of direct reports. The individual in this position is expected to operate autonomously within established systems while proposing opportunities to improve and implement new systems to increase site compliance and team efficiency. Essential responsibilities include:

1. Receive tasking and expectations from QA Management and communicate necessary support required to achieve expected outcomes and deadlines.
2. Provide oversight for daily operations of direct reports.
3. Ensure objectives, goals, training, and timelines are appropriate for direct reports to meet the expectations. Communicate any discrepancies and propose solutions.
4. Provide training to the site for use of the quality systems.
5. Independently provide real time problem solving support to the site when potential quality impacting events occur. Escalate events which require more senior level engagement and propose solutions.
6. Collect and report metrics for department resource utilization and site compliance. Elevate and propose responses to trends.
7. Escalate quality impacting events within established communication systems. Identify when established systems are insufficient and escalate to appropriate parties.
8. Create and maintain procedures governing the use and monitoring of quality systems including, Deviation Management, CAPAs, Change Control, Management Notifications, and Quality Management Review. Reference and apply regulatory requirements and guidance including but not limited to those governing parenteral drugs and medical devices marketed in the USA, EU, Japan, Russia, Korea, Turkey, and Brazil.
9. Maintain the appropriate staffing levels and supervise performance of direct reports. Engage in recruiting, coaching, and recognition activities.
10. Interface with and support clients in alignment with Quality Service Agreements.
11. Independently implement new systems as needed to facilitate team objectives.
12. Execute Final Approver responsibility for documents within the quality system as appropriate for a QA Supervisor.
13. Lead multidisciplinary teams to achieve site objectives as required.
14. Identify opportunities and propose solutions to increase departmental efficiency and compliance

Qualifications:

Supervisor I:

• Associates of Arts or Science desired.
• Minimum of 5 years related experience required OR Bachelor's degree and 3 years' experience required.
• Lead and supervisory experience desired.
• Pharmaceutical and FDA regulated industry experience required.
• Experience with technical writing, investigations, CAPA system, Change Control, building and manufacturing processes/systems, QA operations, and QC analysis is required.
• Must be able to execute Final Approver responsibility for documents within the quality system as appropriate for a QA Supervisor.
• Ability to manage conflict, good problem solving ability required.
• Must be able to develop and effectively present training programs for the laboratory personnel that relate to safety, cGMP's, and job training.
• Must be able to participate in multidisciplinary teams to achieve site objectives as required.
• Prolonged sitting required.

Supervisor II (In addition to above):

• Associates of Arts or Science required. Bachelor of Arts or Science desired.
• Minimum of 7 years related experience required OR Bachelor's degree and 4 years' experience required.
• Lead and supervisory experience required.
• Must be able to independently implement new systems as needed to facilitate team objectives.
• Must be able to identify opportunities and propose solutions to increase departmental efficiency and compliance.
• Must be able to lead multidisciplinary teams to achieve site objectives as required.

Shift: Days

Compensation:

• Supervisor I - The salary range for this position is $67,725 - $93,500 depending on experience.
• Supervisor II - The salary range for this position is $68,250 - $107,250 depending on experience.

Benefits:

• 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

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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: