Lead Associate, QA Compliance

About the role

Jubilant HollisterStier LLC is a contract manufacturer of sterile injectable vials and lyophilized products, as well as a worldwide leader in the manufacture of allergenic extracts. This position supports the company's commitment to quality, safety, and innovation.

Responsibilities

• Supports the Deviations, Corrective and Preventive Action (CAPA) program by conducting Root Cause Analysis (RCA) of deviations and vendor complaints/issues.
• Affirm product compliance and product safety.
• Ensures accurate and timely data entry and oversight of Quality Systems related to Deviations, CAPA, and vendor complaint activities.
• Reviews deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs/Policies, Specifications, and related guidelines/regulations.
• Facilitates deviations investigation/resolution, assesses product impact, and completes/writes 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.
• Provides 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.
• Interfaces with management and responsible individuals to assure task completion on or before established due dates.
• Supports quality systems, processes, and procedures (e.g. Deviations, CAPA, Vendor complaint, etc...) to assure compliance and product quality and safety.
• Assists QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
• Provides deviations and CAPA metrics as needed in support of management review of system data.
• Works 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.
• Provides investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
• Speaks to deviations during regulatory and client audits.
• Aids in reviews and approvals of minor deviations in the QMS system.
• Aids in RCA chart review for the QAC team members.
• Acts as QA SME on Change Control records within the QMS.
• Reports performance issues to QAC supervisor as they arise.
• Acts as QA Compliance Supervisor when requested by the QA Manager (in the absence of the supervisor).

Qualifications

• Associates 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.

Pay & Benefits

This is an on-site, full-time position located in Spokane, WA. Hiring Wage: $77,969.00 – $101,200 annually depending on experience, with opportunity for growth, promotion, and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role.

• 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

Shift

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

Application

If you require assistance applying for a position, please contact our HR Department at: JHS-TalentAcquisition@jubl.com