Jubilant HollisterStier CMO
Auditor II/III, Compliance
Jubilant HollisterStier CMO, Spokane, Washington, United States, 99254
Overview
Auditor II/III, Compliance at Jubilant HollisterStier CMO This is an on-site, full-time position located in Spokane, WA. The Compliance Auditor II/III is a highly visible operational role within the Corporate Quality Compliance Team. The incumbent ensures adherence to all cGMPs, FDA and applicable international regulations, guidance documents and standards through internal and supplier audits. The role involves managing Internal and Supplier Audit Programs for GMP, GDP and GLP compliance, collaborating with operational functions to define and review processes, procedures, and systems to be audited annually, and developing a holistic Quality auditing strategy with GXP operational groups and Quality Systems.
Responsibilities
Ensure Jubilant HollisterStier meets regulatory expectations and customer needs by auditing/monitoring key suppliers providing materials or services for GMP activities, assessing compliance with current GMP regulations, Jubilant policies, directives and procedures. Develop, maintain and execute Internal and Supplier audit programs and conduct GXP audits per the audit schedule. Create and execute a systematic approach to audits, presenting findings and recommended changes for non-compliance. Manage Internal Audit and Supplier qualification programs, including audit schedules, SOPs, Approved Supplier List (TrackWise PR records), and Supplier Quality Agreements. Plan scope and schedule audits with internal departments and suppliers, creating an audit plan and identifying resources as needed. Issue audit observations and reports by required deadlines with minimal edits from approvers. Review and evaluate audit responses, determine acceptability, implement CAPAs, and track resolution in the approved audit system. Lead for-cause audits as required for suspected critical audit findings, fraud, or misconduct related to suppliers or internal processes. Report metrics to Site, Department and Corporate Quality management. Support readiness for regulatory inspections and assist site operations during inspections, co-hosting as required. Complete department-related Change Controls, CAPAs and Deviations as needed. Work cross-functionally on improvement projects related to audit compliance, supplier qualification, and other quality-related subjects; review component specifications and SAP source lists; support compliance efforts on new suppliers/materials.
Qualifications
Auditor II: Bachelor’s degree in a related professional technical or life sciences field or equivalent combination of education and experience. CQA or equivalent desired but not required. Minimum five (5) years of related experience, including Quality Unit experience. Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits preferred. Experience with regulatory authorities and/or regulatory inspections desired. Knowledge of CFR, EU guidance, ISO and other industry regulations; ability to interpret GMPs and quality systems; ability to inspect and identify deficiencies. Proficient in Word, Excel, PowerPoint; working knowledge of SAP and TrackWise. Potential travel 10% - 40% Requires use of personal protective equipment in designated areas. Auditor III:
In addition to the above, Minimum ten (10) years of related experience, including Quality Unit experience. Minimum of five (5) years of experience in a Pharmaceutical or FDA-regulated environment.
Shift:
Weekday Days, Monday-Friday This is an on-site, full-time position located in Spokane, WA.
Compensation
Auditor II: $77,968 - $101,200 Auditor III: $77,968 - $113,900 annually, with opportunity for growth, promotion and annual raises.
Benefits
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
Additional information
Jubilant HollisterStier 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 JHS-TalentAcquisition@jubl.com.
Equal Opportunity Employer statements and contact information are provided in accordance with applicable law.
How to apply:
Visit Jubilant career site for Spokane, WA link and apply online.
#J-18808-Ljbffr
Auditor II/III, Compliance at Jubilant HollisterStier CMO This is an on-site, full-time position located in Spokane, WA. The Compliance Auditor II/III is a highly visible operational role within the Corporate Quality Compliance Team. The incumbent ensures adherence to all cGMPs, FDA and applicable international regulations, guidance documents and standards through internal and supplier audits. The role involves managing Internal and Supplier Audit Programs for GMP, GDP and GLP compliance, collaborating with operational functions to define and review processes, procedures, and systems to be audited annually, and developing a holistic Quality auditing strategy with GXP operational groups and Quality Systems.
Responsibilities
Ensure Jubilant HollisterStier meets regulatory expectations and customer needs by auditing/monitoring key suppliers providing materials or services for GMP activities, assessing compliance with current GMP regulations, Jubilant policies, directives and procedures. Develop, maintain and execute Internal and Supplier audit programs and conduct GXP audits per the audit schedule. Create and execute a systematic approach to audits, presenting findings and recommended changes for non-compliance. Manage Internal Audit and Supplier qualification programs, including audit schedules, SOPs, Approved Supplier List (TrackWise PR records), and Supplier Quality Agreements. Plan scope and schedule audits with internal departments and suppliers, creating an audit plan and identifying resources as needed. Issue audit observations and reports by required deadlines with minimal edits from approvers. Review and evaluate audit responses, determine acceptability, implement CAPAs, and track resolution in the approved audit system. Lead for-cause audits as required for suspected critical audit findings, fraud, or misconduct related to suppliers or internal processes. Report metrics to Site, Department and Corporate Quality management. Support readiness for regulatory inspections and assist site operations during inspections, co-hosting as required. Complete department-related Change Controls, CAPAs and Deviations as needed. Work cross-functionally on improvement projects related to audit compliance, supplier qualification, and other quality-related subjects; review component specifications and SAP source lists; support compliance efforts on new suppliers/materials.
Qualifications
Auditor II: Bachelor’s degree in a related professional technical or life sciences field or equivalent combination of education and experience. CQA or equivalent desired but not required. Minimum five (5) years of related experience, including Quality Unit experience. Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits preferred. Experience with regulatory authorities and/or regulatory inspections desired. Knowledge of CFR, EU guidance, ISO and other industry regulations; ability to interpret GMPs and quality systems; ability to inspect and identify deficiencies. Proficient in Word, Excel, PowerPoint; working knowledge of SAP and TrackWise. Potential travel 10% - 40% Requires use of personal protective equipment in designated areas. Auditor III:
In addition to the above, Minimum ten (10) years of related experience, including Quality Unit experience. Minimum of five (5) years of experience in a Pharmaceutical or FDA-regulated environment.
Shift:
Weekday Days, Monday-Friday This is an on-site, full-time position located in Spokane, WA.
Compensation
Auditor II: $77,968 - $101,200 Auditor III: $77,968 - $113,900 annually, with opportunity for growth, promotion and annual raises.
Benefits
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
Additional information
Jubilant HollisterStier 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 JHS-TalentAcquisition@jubl.com.
Equal Opportunity Employer statements and contact information are provided in accordance with applicable law.
How to apply:
Visit Jubilant career site for Spokane, WA link and apply online.
#J-18808-Ljbffr