QA Compliance Lead - CAPA & Deviations, Spokane

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life Insurance

AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA seeks a QA Compliance Associate to support Deviation, CAPA, and RCA processes. You will ensure product compliance and safety, oversee data entry, and maintain quality systems across Deviation and vendor-complaint activities.

Your role includes leading investigations, drafting reports, interviewing SMEs, and coordinating corrective actions with QA and management while ensuring timely, compliant closures.

Qualifications

• Associate degree in biology or chemistry required.
• Bachelor's degree in science required or preferred.
• 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, QA operations systems, and QC analysis 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/Policies.
• Interview SMEs and involved employees across shifts to investigate problems and assess quality impact.
• 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 with stakeholders to identify improvements.
• Develop CAPA actions with cross-functional teams.
• Ensure investigations and CAPA are generated and approved in a timely manner.
• Assist in client calls and audits as liaison for investigations.
• Support data collection for management reviews, KPI reports, and client trend meetings.

Skills

Root cause analysis

Investigations

CAPA system

QA operations

cGMPs knowledge

Education

Associate's degree in biology, Chemistry or related field

Bachelor's degree in a science field

Tools

Microsoft Word

Microsoft Excel

SOP writing

Job description

Jubilant HollisterStier LLC in Spokane, WA seeks a QA Compliance Associate to support Deviation, CAPA, and RCA processes. You will ensure product compliance and safety, oversee data entry, and maintain quality systems across Deviation and vendor-complaint activities.

Your role includes leading investigations, drafting reports, interviewing SMEs, and coordinating corrective actions with QA and management while ensuring timely, compliant closures.