Senior QA Compliance Associate - CAPA & RCA Lead

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

FSA/HSA

Life Insurance

AD&D

Disability benefits start immediately

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a Sr. Associate/Associate QA Compliance to support Deviations, CAPA and RCA activities ensuring product safety and regulatory compliance. You will review investigations, write final assessments, and coordinate with QA and management to meet timelines.

The role requires experience in QA, CAPA, deviations, and GMP knowledge; cross-functional collaboration is essential to drive improvements and client readiness during audits.

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in lieu of an Associate’s degree.
• Bachelor’s Degree in a science field desired.
• Sologic Certificate desired.
• Minimum 2 years of experience required; degree may substitute for experience.
• Pharmaceutical/FDA regulated industry experience desired.
• Experience with investigations, CAPA, QC analysis and writing.
• Direct or supporting aseptic manufacturing experience desired.
• Microsoft Word & Excel required.
• Knowledge of cGMPs desired.

Responsibilities

• Review Deviations, investigations and CAPAs for accuracy, consistency and compliance.
• Facilitate Deviations investigations and assess product impact; prepare final assessments.
• Enter data into database to support RCA and CAPA activities.
• Oversee RCA meetings, publish minutes, and follow up on actions.
• Interface with management to ensure timely task completion.
• Support quality systems to assure compliance and product safety.
• Assist with implementing corrective actions from deviations, audits or inspections.
• Provide Deviations and CAPA metrics for management review.
• Coordinate with cross functional teams to capture details for investigations.

Skills

Problem solving

Attention to detail

Regulatory understanding

Education

Associate degree in Biology, Chemistry or related field

Bachelor’s Degree in a science field desired

Sologic Certificate desired

Tools

Microsoft Word

Microsoft Excel

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a Sr. Associate/Associate QA Compliance to support Deviations, CAPA and RCA activities ensuring product safety and regulatory compliance. You will review investigations, write final assessments, and coordinate with QA and management to meet timelines.

The role requires experience in QA, CAPA, deviations, and GMP knowledge; cross-functional collaboration is essential to drive improvements and client readiness during audits.