Associate, QA Compliance

Job Description

The QA Compliance Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. 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.

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.

Preferred

• Bachelor’s Degree in a science field desired.
• Sologic Certificate Pharmaceutical and FDA regulated industry experience desired.
• Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Knowledge of cGMPs desired.

Location

Spokane, WA — On Site, Full-Time

Shift

Monday-Friday 8am-5pm

Compensation & Benefits

Hiring Wage: $32.01–$37.65 hourly, with opportunities for growth, promotion, and annual raises. At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success. Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Our Promise

Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.