QA Compliance Specialist — Deviations & CAPA Expert

Jubilant Pharma Limited; Spokane (WA); On-site; USD 44,000 - 52,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA

Life Insurance

AD&D

Disability insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is hiring a QA Compliance Associate to support deviations, CAPA and root cause analysis within a fast-paced pharmaceutical quality system. You will work with cross-functional teams to ensure product compliance and timely data entry, with a focus on investigation accuracy and regulatory alignment.

The role involves leading investigations, drafting reports, coordinating immediate actions, and communicating findings during client calls and audits.

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in a lieu of an Associate’s degree.
• Minimum 2 years of experience required. Bachelor’s degree can be used in lieu of experience.
• Microsoft Word & Excel required.
• Managing conflict and influencing outcomes desired.
• Provides analysis, diagnosis or production tasks which noticeably impact end results.

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 applicable SOPs/Policies, Specifications and related guidelines/regulations.
• Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.
• Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP.
• Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance.
• Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors.
• Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.
• Work with cross functional team member(s) to develop appropriate CAPA actions.
• Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
• Act as liaison as it relates to specific investigations during client calls and audits.
• Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms.
• Communicate/Escalate to management any issues or delays identified during the investigation process.

Skills

Conflict management

Influencing outcomes

Analytical thinking

Education

Associate's Degree in Biology, Chemistry or related field

Tools

Microsoft Word

Microsoft Excel

Job description

Jubilant HollisterStier LLC in Spokane, WA is hiring a QA Compliance Associate to support deviations, CAPA and root cause analysis within a fast-paced pharmaceutical quality system. You will work with cross-functional teams to ensure product compliance and timely data entry, with a focus on investigation accuracy and regulatory alignment.

The role involves leading investigations, drafting reports, coordinating immediate actions, and communicating findings during client calls and audits.