Jubilant Pharma Limited
Auditor II/III, Compliance
Jubilant Pharma Limited, Spokane, Washington, United States, 99254
Overview
Jubilant HollisterStier LLC, Spokane’s largest manufacturing company and a proud member of the Jubilant Pharma family, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials and lyophilized products. The Allergy business is a worldwide leader in allergenic extracts. Our promise is Caring, Sharing, Growing, and delivering innovative, cost-effective solutions for customers and stakeholders. Job Description:
The
Compliance Auditor II/III
is a highly visible operational position within the Corporate Quality Compliance Team. The role ensures the company adheres to all cGMPs, FDA and applicable international regulations, guidance documents, and standards through internal audits. The incumbent manages the Internal Audit and Supplier Audit Programs for GMP, GDP and GLP compliance, working with operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent coordinates and develops a holistic Quality auditing strategy with GXP operational groups and Quality Systems. Responsibilities
Audit and monitor key suppliers that provide material or services used for GMP activities to ensure regulatory agencies’ expectations and customers’ needs are met. Develop, maintain, and execute the Internal and Supplier audit programs and conduct GXP audits per the audit schedule, including but not limited to. Establish a systematic approach to all audits, present findings, and recommend changes to procedures or practices not in compliance with regulations. Manage the Internal Audit and Supplier qualification programs, including audit schedules, SOPs, Approved Supplier List, TrackWise records, and Supplier Quality Agreements. Plan audit scope and schedule with internal departments and suppliers, creating audit plans and identifying resources as needed. Issue audit observations and reports by required deadlines with minimal edits from the approver. Review and evaluate audit responses, determine acceptability, and implement CAPAs to resolve issues; follow up in the approved audit tracking system. Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to suppliers or internal processes. Report metrics to Site, Department, and Corporate Quality management. Support facility readiness for regulatory inspections; assist site operations during inspections and co-host as required. Complete department-related Change Controls, CAPAs, and Deviations; work cross-functionally on improvement projects related to audit compliance, supplier qualification, and other quality subjects. Review and approve component specifications and SAP source lists; support compliance efforts and represent QA on projects related to new suppliers or 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 conducting supplier and internal audits. Experience with regulatory authorities and/or regulatory inspections desired. Knowledge of CFRs, EU guidance, ISO, GMPs and quality systems; ability to inspect and identify deficiencies in documents, products, and processes. Proficient in Microsoft Office; working knowledge of SAP and TrackWise. Potential travel 10% – 40%. Requires use of personal protective equipment in designated areas. Auditor III: Minimum ten (10) years of related experience with Quality Unit experience. Minimum five (5) years of experience in a pharmaceutical or FDA-regulated environment. Additional Details
Shift:
Weekday Days, Monday–Friday Compensation & Benefits:
This is an
on-site, full-time
position located in Spokane, WA. Auditor II: $78,200 – $101,200 annual Auditor III: $88,000 – $113,900 annual, with opportunities for growth and annual raises. See full benefits list below for the compensation package. Medical, Dental, Vision, Flexible Spending Accounts Health Savings Accounts Life, AD&D, Short and Long Term Disability 401(k) with company match Generous paid time off Employee Assistance Program 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 Visit: Jubilant career site for Spokane, WA link. Referrals increase your chances of interviewing at Jubilant Pharma Limited. Seniority level: Mid-Senior level • Employment type: Full-time • Job function: Finance and Sales • Industries: Pharmaceutical Manufacturing
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Jubilant HollisterStier LLC, Spokane’s largest manufacturing company and a proud member of the Jubilant Pharma family, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials and lyophilized products. The Allergy business is a worldwide leader in allergenic extracts. Our promise is Caring, Sharing, Growing, and delivering innovative, cost-effective solutions for customers and stakeholders. Job Description:
The
Compliance Auditor II/III
is a highly visible operational position within the Corporate Quality Compliance Team. The role ensures the company adheres to all cGMPs, FDA and applicable international regulations, guidance documents, and standards through internal audits. The incumbent manages the Internal Audit and Supplier Audit Programs for GMP, GDP and GLP compliance, working with operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent coordinates and develops a holistic Quality auditing strategy with GXP operational groups and Quality Systems. Responsibilities
Audit and monitor key suppliers that provide material or services used for GMP activities to ensure regulatory agencies’ expectations and customers’ needs are met. Develop, maintain, and execute the Internal and Supplier audit programs and conduct GXP audits per the audit schedule, including but not limited to. Establish a systematic approach to all audits, present findings, and recommend changes to procedures or practices not in compliance with regulations. Manage the Internal Audit and Supplier qualification programs, including audit schedules, SOPs, Approved Supplier List, TrackWise records, and Supplier Quality Agreements. Plan audit scope and schedule with internal departments and suppliers, creating audit plans and identifying resources as needed. Issue audit observations and reports by required deadlines with minimal edits from the approver. Review and evaluate audit responses, determine acceptability, and implement CAPAs to resolve issues; follow up in the approved audit tracking system. Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to suppliers or internal processes. Report metrics to Site, Department, and Corporate Quality management. Support facility readiness for regulatory inspections; assist site operations during inspections and co-host as required. Complete department-related Change Controls, CAPAs, and Deviations; work cross-functionally on improvement projects related to audit compliance, supplier qualification, and other quality subjects. Review and approve component specifications and SAP source lists; support compliance efforts and represent QA on projects related to new suppliers or 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 conducting supplier and internal audits. Experience with regulatory authorities and/or regulatory inspections desired. Knowledge of CFRs, EU guidance, ISO, GMPs and quality systems; ability to inspect and identify deficiencies in documents, products, and processes. Proficient in Microsoft Office; working knowledge of SAP and TrackWise. Potential travel 10% – 40%. Requires use of personal protective equipment in designated areas. Auditor III: Minimum ten (10) years of related experience with Quality Unit experience. Minimum five (5) years of experience in a pharmaceutical or FDA-regulated environment. Additional Details
Shift:
Weekday Days, Monday–Friday Compensation & Benefits:
This is an
on-site, full-time
position located in Spokane, WA. Auditor II: $78,200 – $101,200 annual Auditor III: $88,000 – $113,900 annual, with opportunities for growth and annual raises. See full benefits list below for the compensation package. Medical, Dental, Vision, Flexible Spending Accounts Health Savings Accounts Life, AD&D, Short and Long Term Disability 401(k) with company match Generous paid time off Employee Assistance Program 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 Visit: Jubilant career site for Spokane, WA link. Referrals increase your chances of interviewing at Jubilant Pharma Limited. Seniority level: Mid-Senior level • Employment type: Full-time • Job function: Finance and Sales • Industries: Pharmaceutical Manufacturing
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