QA Compliance Specialist - Deviation & CAPA Lead

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

Benefits offered by this job

Medical, Dental, Vision

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a QA Compliance Associate to support the CAPA program through RCA of deviations and vendor issues. You will ensure product compliance, safety, and timely data entry within the quality systems.

The role involves leading investigations, drafting reports, and coordinating cross-functional actions to meet SOPs and regulatory standards. Qualifications include an Associate degree in biology or chemistry (or related field) with pharma/FDA

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• Bachelor’s Degree in a science field desired.
• Sologic Certificate is required.
• 5+ years related experience with an Associate’s Degree.
• 2+ years related experience with a Bachelor degree.
• Pharmaceutical and FDA regulated experience 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 multiple shifts to investigate reported problems.
• Coordinate immediate actions with QA and management upon non-conformance.
• Utilize problem solving techniques to determine root cause.

Skills

cGMP knowledge

Verbal and written communication

Conflict management

Prioritization

QA documentation tools

Aseptic manufacturing experience

Education

Associate degree in Biology, Chemistry or related field

Bachelor’s degree in a science field

Tools

CAPA system

Quality Assurance SOPs

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a QA Compliance Associate to support the CAPA program through RCA of deviations and vendor issues. You will ensure product compliance, safety, and timely data entry within the quality systems.

The role involves leading investigations, drafting reports, and coordinating cross-functional actions to meet SOPs and regulatory standards. Qualifications include an Associate degree in biology or chemistry (or related field) with pharma/FDA