Lead QA Compliance Investigator

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 82,000 - 131,000; Full time

Benefits offered by this job

Medical, Dental, Vision

FSA/HSA

Life Insurance

AD&D

Disability insurance

Job summary

Jubilant HollisterStier Spokane is an equal opportunity employer located in Spokane, WA. The company seeks a quality investigations professional to lead deviations, draft reports, and ensure timely, compliant investigations within a GMP environment.

Location: Spokane, WA — On Site, Full-Time. Compensation range $81,800–$130,900 with potential growth and comprehensive benefits starting day one.

Qualifications

• Minimum 5 years related experience with an Associate’s degree.
• Minimum 2 years related experience with a Bachelor’s degree.
• Pharmaceutical and FDA regulated experience required.
• Experience with technical writing, investigations, CAPA system and QA operations.
• Knowledge of cGMPs required.

Responsibilities

• Lead, facilitate, and conduct deviations, non-conformances investigations.
• Author/draft investigation reports with minimal guidance.
• Ensure timely completion of investigations with accuracy and compliance with SOPs.
• Interview SMEs and employees across shifts to investigate problems and assess quality impact.
• Conduct investigational meetings and verify findings against SOP documentation.
• Coordinate immediate actions with QA and management upon non-conformance.
• Utilize problem solving techniques to determine root cause and causal factors.
• Facilitate root cause analysis meetings to identify solutions for quality improvements.
• Develop CAPA actions with cross functional teams.
• Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
• Act as liaison during client calls and audits.
• Support data collection for management reviews and KPI reports.
• Escalate issues or delays to management as needed.
• Provide investigation training to QA and other departments.
• Speak to assigned deviations during regulatory and client audits.
• Act as the QAC Lead Associate when requested by QAC Supervisor.

Skills

Investigations

CAPA system

Technical writing

QA operations

Education

Associate’s degree in biology/chemistry or related field

Bachelor’s degree in science

Job description

Jubilant HollisterStier Spokane is an equal opportunity employer located in Spokane, WA. The company seeks a quality investigations professional to lead deviations, draft reports, and ensure timely, compliant investigations within a GMP environment.

Location: Spokane, WA — On Site, Full-Time. Compensation range $81,800–$130,900 with potential growth and comprehensive benefits starting day one.