Lead Associate, QA Compliance- Nights

Jubilant Hollister Stier 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 Hollister Stier 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, primarily used for treating allergies and asthma.

Jubilant Hollister Stier is a proud member of the Jubilant Pharma family.

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 (RCA) of deviations and vendor complaints/issues. The role ensures product compliance and safety, and guarantees accurate, timely data entry and oversight of the 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 completing/writing final assessment/lot disposition for QA Management and Client review and approval.
• Enter 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.
• Support quality systems, processes and procedures (e.g., Deviations, CAPA, Vendor complaint, etc.) to assure compliance and product quality and safety.
• Assist the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audits 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 experience 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

• Hiring Wage: $77,969.00 – $101,200 annually depending on experience, with opportunity for growth, promotion and annual raises.…