39127_Compliance, Lead Associate

Jubilant HollisterStier • Spokane, WA • 16h ago

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job 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.

6.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 process 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)

Qualifications:

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