QA Compliance Lead - CAPA & Deviations Expert

Jubilant Life Sciences Ltd.; Spokane (WA); On-site; USD 56,000 - 66,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier CMO in Spokane, WA is hiring a Lead Associate - QA Compliance to support Deviations, CAPA, and RCA activities on-site. The role ensures product compliance and timely data entry within Quality Systems, with opportunities to lead investigations and mentor the QA team.

Minimum qualifications include an Associate’s Degree in a science field, 5–10 years of related experience, and FDA-regulated industry knowledge.

Qualifications

• 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.
• 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.

Responsibilities

• 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.
• 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)

Skills

Technical writing

Investigations

CAPA system

QA operations systems

QC analysis

Microsoft Word

Education

Associates Degree in Biology, Chemistry or related field

Bachelor’s Degree in a science field

Tools

Microsoft Excel

Job description

Jubilant HollisterStier CMO in Spokane, WA is hiring a Lead Associate - QA Compliance to support Deviations, CAPA, and RCA activities on-site. The role ensures product compliance and timely data entry within Quality Systems, with opportunities to lead investigations and mentor the QA team.

Minimum qualifications include an Associate’s Degree in a science field, 5–10 years of related experience, and FDA-regulated industry knowledge.