Lead Associate, QA Compliance

Jubilant Hollister Stier LLC,
Spokane’s Largest Manufacturing Company
, is a nationally recognized contract manufacturer of sterile injectable vials, lyophilized products, and allergenic extracts.

Our Promise:
Caring, Sharing, Growing.

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 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 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)

• Associate’s Degree in Biology, Chemistry or related field required.
• Bachelor’s Degree in a science field desired.
• 5 to 10 years related experience required with an Associate’s Degree required.
• Minimum of 3 years related experience required with a Bachelor’s Degree required.
• 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.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Lead and Supervisory desired.
• Ability to lift 30 pounds unassisted required.
• Microsoft Word & Excel experience required.
• Knowledge of cGMPs desired.
• Prolonged sitting required.

Weekday Nights, Monday-Wednesday E/O Thursday 6pm-6am

This is an on-site, full-time position located in Spokane,…