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# Lead Associate - QA Compliance

- **Company:** JUBILANT HOLLISTERSTIER LLC
- **Location:** Spokane, WA, United States
- **Experience:** Expert
- **Salary:** $84,968 - $99,965
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Databases, Operational Systems
- **Published:** October 27, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=1edd2e88a4ade520

## About the Role

* Associates Degree in Biology, Chemistry or related field required.
 * 5 to 10 years related experience required with an Associate'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.

Preferred:

 * Bachelor's Degree in a science field desired.
 * Minimum of 3 years related experience required with a Bachelor's Degree.
 * Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
 * Lead Experience.
 * Supervisory Experience.
 * Knowledge of cGMPs desired.

Working Environment:

 * Ability to lift 30 pounds unassisted.
 * Prolonged sitting required.

## Description

The QA Compliance Lead 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.

 * Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
 * Accountable for facilitating deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
 * Enters data into database in support of the corporate RCA and CAPA activities.
 * Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
 * Interface with management and responsible individuals to assure task completion on or before established due dates.
 * Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc.…) to assure compliance and product quality and safety.
 * Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
 * Provide deviations and CAPA metrics as needed in support of management review of system data.
 * Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
 * Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
 * Speak to deviations during regulatory and client audits.
 * Assist with reviews and approval of minor deviations in the QMS system.
 * Assist with extension requests approvals when permitted by procedure.
 * Assist with RCA chart review for the QAC team members.
 * Act as QA SME on Change Control records within the QMS.
 * Provide leadership and guidance to QAC team members.
 * Report performance issues to QAC supervisor as they arise.
 * Act as the QA Compliance Supervisor when requested by the QA Manager. (In the absence of the supervisor)