QA Oversight Specialist Weekday Nights Mon - Wed & EO Thurs

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:

The QA Oversight Specialist provides support to all functions associated with manufacturing and quality control operations via daily on-the-floor support. The oversight includes evaluation and review of ongoing Manufacturing and Quality Control Operations, and management of all Quality functions related to facility, systems, and manufacturing support. Other areas include (but are not limited to) Metrology, Engineering, Maintenance, and Information Systems (IS). Essential responsibilities include:

1. Ensure that all applicable US and European regulatory requirements are being met within the procedures and practices of the Manufacturing and Quality Control units.
2. Conduct on the floor oversight of the Manufacturing and QC facilities to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP).
3. Provide necessary daily, weekly and monthly summaries and reviews for on the floor observations, provide responses to observations and ensure that all corrective action measures are completed as described and within the timeframe given in the response.
4. Recognize potential problems and review and approve proposed mitigations, or document problems encountered, collaborating with department supervisors to ensure that quality requirements are clearly communicated to resolve any deficiencies in product quality or manufacturing systems and procedures.
5. Ensure that investigations related to deviations in facility or support systems are complete and adequate.
6. Position requires the ability to solve complex problems independently and within a team environment.
7. QA oversight of aseptic processing.
8. Assist in training of any new QA Oversight personnel.
9. Provide review/approval on Quality system records.
10. Seek continuous improvement by revising SOPs related to job function in order to meet industry standards.

Qualifications:

• Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degree.
• Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience
• FDA regulated industry experience required.
• Proficiency In Microsoft Word, Excel And PowerPoint Required
• Mechanical Aptitude Desired
• In-Depth Understanding of the Relationship between Regulatory Requirements, Operating Procedures, and Ensuring Compliance in a Production Environment required.
• Able to Follow Detailed Instructions required.
• Exposure to allergens, working in Aseptic areas, and prolonged sitting and standing required.

Shift: Weekday Nights Mon - Wed & Every Other Thursday. 6pm - 6am *rotating 3x12 & 4x12 shifts

Compensation & Benefits:

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

• Hiring Wage: $67,725 - $101,200 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