On-Site Operations Lead, Inspection — Drive GMP Excellence

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 102,000 - 136,000; Full time

Benefits offered by this job

FSA/HSA

Life Insurance

AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking an Operations Lead, Inspection to drive operational excellence within shift manufacturing teams. You will provide technical and operational support, maintain equipment knowledge, and ensure readiness for qualification and validation activities.

You will lead improvement projects, support cross-functional teams, and help develop Standard Operating Procedures and batch records while mentoring new personnel.

Qualifications

• Bachelor's degree required; 5+ years experience in lieu of degree acceptable with HS degree.
• Experience in project management and coordination.
• Strong analytical skills and data analysis proficiency.
• Effective communication across audiences.
• Ability to influence across multiple levels and functions.
• PPE required in manufacturing areas.
• Exposure to allergens and aseptic work environments.

Responsibilities

• Provide Subject Matter expertise on industry standards, best practices, and site capabilities to enable successful integration of new products and processed into existing and future facility inspection equipment.
• Support and own development of inspection test sets, authoring means and methods for performing inspection, and best practices for inspection qualification & requalification.
• Serve as a key integrator for cross-functional teams supporting seamless operation of cGMP production, ensuring readiness of manufacturing areas for start-up, process qualification, and validation activities.
• Support the manufacturing operations team as a key contributor for projects that implement new technologies and operational process improvements in the GMP manufacturing environment, maintaining processing suites in a compliant and validated state.
• Lead or participate in continuous improvement projects, including capacity optimization and cost reduction programs.
• Support the development of the Operational Excellence programs and lead Manufacturing Projects with cross-functional stakeholders.
• Work with cross functional teams to review, author and revise standard operating procedures and batch records, review technical reports, assist with conducting deviation investigations, and write deviation reports.
• Document and communicate all aspects of work and learnings, providing training and mentorship for new personnel.
• Assist with metrics tracking and reporting to leadership teams.
• Support and participate in internal and external regulatory inspections as necessary.

Skills

Analytical skills

Microsoft Office

Production planning

Leading and influencing

Effective communication

Conflict management

Leadership

Willingness to work in PPE

Education

Bachelor's degree in Engineering, Operations, or Life Sciences

5+ years experience in lieu of a degree (HS degree required)

Tools

Microsoft Office

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking an Operations Lead, Inspection to drive operational excellence within shift manufacturing teams. You will provide technical and operational support, maintain equipment knowledge, and ensure readiness for qualification and validation activities.

You will lead improvement projects, support cross-functional teams, and help develop Standard Operating Procedures and batch records while mentoring new personnel.