Senior QA Compliance Lead — CAPA & Deviation Expert

Jubilant Pharma Limited; Spokane (WA, MO); On-site; USD 82,000 - 109,000; Full time

Benefits offered by this job

Medical, Dental & Vision

FSA/HSA

Life Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA seeks a Sr. Associate, QA Compliance to support the Deviation, CAPA, and QMS processes. You will lead investigations, draft reports, and ensure timely closure in alignment with SOPs.

You will collaborate with cross-functional teams, provide training as needed, and support regulatory audits. This role emphasizes strong writing, regulatory knowledge, and leadership in quality systems.

Qualifications

• Associates Degree in Biology, Chemistry or related field.
• Bachelor’s Degree in a science field preferred.
• Sologic Certificate.
• Minimum of 5 years related experience with an Associate’s Degree.
• Minimum of 2 years related experience with a Bachelor degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with investigations, CAPA system, QA operations systems, and QC analysis is required.

Responsibilities

• Lead, facilitate, and conduct deviations, non-conformances investigations.
• Author/draft investigation reports with minimal guidance.
• Ensure timely completion of investigations with accuracy, consistency and compliance with SOPs/Policies.
• Interview SMEs and involved employees across shifts to investigate problems.
• Conduct investigational meetings and verify findings against SOPs.
• Coordinate immediate actions with QA and management on non-conformances.
• Use problem solving tools to determine root cause and causal factors.
• Facilitate RCA meetings to identify quality improvement solutions.
• Develop CAPA actions with cross-functional teams.
• Ensure investigations, corrections and CAPA are generated and approved timely.
• Act as liaison during client calls and audits.
• Support data collection for management reviews and KPI reports.
• Communicate issues or delays to management.

Skills

Regulatory compliance

Root cause analysis

CAPA investigations

Technical writing

Cross-functional collaboration

Education

Associates Degree in Biology, Chemistry or related field

Bachelor’s Degree in a science field

Sologic Certificate

Tools

Microsoft Word

Microsoft Excel

Job description

Jubilant HollisterStier LLC in Spokane, WA seeks a Sr. Associate, QA Compliance to support the Deviation, CAPA, and QMS processes. You will lead investigations, draft reports, and ensure timely closure in alignment with SOPs.

You will collaborate with cross-functional teams, provide training as needed, and support regulatory audits. This role emphasizes strong writing, regulatory knowledge, and leadership in quality systems.