Lead Associate, QA Compliance

Lead Associate, QA Compliance

Jubilant Pharma Limited (Jubilant Hollister Stier LLC, Spokane’s Largest Manufacturing Company) invites applications for the Lead Associate, QA Compliance role. This on‑site full‑time position is located in Spokane, WA.

• Review deviations, investigations, and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
• Facilitate deviations investigation/resolution, assess product impact and complete/writing final assessment/lot disposition for QA Management and client review and approval.
• Enter data into database to support corporate RCA and CAPA activities.
• Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to participants, publishing meeting minutes, and following up on agreed activities and tasks.
• Interface with management and responsible individuals to assure task completion on or before established due dates.
• Support quality systems, processes and procedures (e.g., Deviations, CAPA, Vendor complaint, etc.) to assure compliance and product quality and safety.
• Assist 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 to support management review of system data.
• Work extensively with appropriate departments 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 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 request 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 the bio/pharma industry desired.
• Lead and Supervisory experience desired.
• Ability to lift 30 pounds unassisted required.
• Prolonged sitting required.

Weekday days, Monday‑Friday

• Hiring wage: $77,969.00 – $101,200 annually, depending on experience, with opportunities for growth, promotion and annual raises.
• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts.
• Life, AD&D, Short and Long Term Disability.
• 401(k) with company match.
• Generous paid time off plan.
• Employee Assistance Program.

Unlock your potential with Jubilant Hollister Stier! If you’re seeking a dynamic and rewarding career, we welcome your application today!

Jubilant Hollister Stier is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you require assistance applying for a position, please contact our HR Department at: J