QA Compliance Specialist - CAPA & Deviation

Xtalks; Spokane (WA); On-site; USD 82,000 - 131,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

FSA/HSAs

Life & AD&D Insurance

Short-Term & Long-Term Disability

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA, is seeking a QA Compliance Associate to support the Deviation, CAPA and RCA processes, ensuring product compliance and timely data entry within Quality Systems.

You will lead investigations, draft reports, coordinate CAPA actions, and support client audits with cross-functional teams on-site. Strong pharma/regulatory background is required; starting wage range is $81,800–$130,900.

Qualifications

• Associate’s degree in biology, chemistry or related field required.
• Bachelor’s degree in a science field desired.
• Minimum of 5 years related experience required with an Associate’s Degree.
• Minimum of 2 years related experience required with a Bachelor’s degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Microsoft Word & Excel required. Knowledge of cGMPs required.

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.
• Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
• Speak to assigned deviations during regulatory and client audits. 16. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate)

Skills

Microsoft Word

Microsoft Excel

Technical writing

Investigations

CAPA system

Education

Associate’s degree in biology, chemistry or related field

Bachelor’s degree in a science field

Tools

CAPA system

Job description

Jubilant HollisterStier LLC in Spokane, WA, is seeking a QA Compliance Associate to support the Deviation, CAPA and RCA processes, ensuring product compliance and timely data entry within Quality Systems.

You will lead investigations, draft reports, coordinate CAPA actions, and support client audits with cross-functional teams on-site. Strong pharma/regulatory background is required; starting wage range is $81,800–$130,900.