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.

The Supervisor, Quality Assurance off Shift provides QA Supervisor document approval, decision-making support, and team development to all QA departments on weekends. To accomplish this purpose, the supervisor will refer to existing procedures and complete the appropriate training to approve necessary documents and forms. They will use available data, guidance, and procedures to evaluate events, which occur and determine the appropriate response given existing documentation. They will develop the QA team members that report to direct supervisors which do not work the same shift and ensure that the team is working efficiently and in alignment with the expectations of each department. They will be responsible for triaging unexpected events and responding in alignment with applicable guidance or procedures, or they will escalate to the appropriate QA on call leadership team member. They data which demonstrates the efficient use of QA resources on the weekend will be collected and reported by the supervisor or a delegate. The supervisor will have the responsibility for ensuring all relevant information is passed down to the weekday QA leadership team. Essential responsibilities include:

1. Receive tasking and expectations from multiple members of QA Management and ensure execution.
2. Provide oversight for daily operations of matrix reports.
3. Provide training to the site for use of the the quality systems.
4. Provide real time problem solving support to the site when potential quality impacting events occur in alignement with existing guidance documents, regulations, and procedures. Escalate events which require more senior level engagement and propose solutions.
5. Collect and report metrics for resource utilization and site compliance. Elevate and propose responses to trends.
6. Escalate quality impacting events within established communication systems. Notify the appropriate QA Manager or potentially impactful events or personnel issues which require resolution beyond real time coaching.
7. Maintain and follow procedures governing the use and monitoring of quality systems. Leverage the expertise of SMEs in the QA departmens working on the weekend. . Reference and apply appropriate regulatory requirements and guidance including but not limited to those governing parentaral drugs and medical devices marketed in the USA, EU, Japan, Korea, Turkey, and Brazil.
8. Supervise and document the performance of matrix reports. Engage in recruiting, coaching, and recognition activities.
9. Interface with and support clients and vendors in alignement with Quality Service Agreements. Ensure the site maintains a state of audit readiness.
10. Propose new systems or resources needed to facilitate team objectives.
11. Clearly communicate quality requirements and evaluate objectively whether or not they have been met.
12. Execute Final Approver responsibility for documents within the quality system as appropriate for a QA Supervisor.
13. Participate in multidisciplinary teams to achieve site objectives as required.

Qualifications:

• Bachelor of Arts or Science Degree and 2 years of experience required OR an Associates of Arts or Science and 5 years' experience required OR 10 year's related experience in lieu of associate's degree.
• Prior supervisory and lead experience desired.
• Must have Pharmaceutical and FDA regulated industry experience.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operation systems, and QC analysis required.
• Proficiency in the use of Microsoft Word, Excel and PowerPoint required.
• Physical Requirements: Ability to lift up to 30 lbs unassisted. Prolong sitting.

Shift: Fri -Sun 4 X12 hrs, Mon. 4hrs.

Compensation:

• The salary range for this position is $67,725 - $93,500 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://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:

HResources@jhs.jubl.com