Compliance Auditor I/Ii/Iii

2-10 years

Not Disclosed

Remote, USA

10 Jan. 23, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Compliance Auditor I/II/III

Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting for a Compliance Auditor I/II/III to join our team!

What We Offer:

We provide a culture that values professional growth and development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a group retirement savings plan, and health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As an integrated contract pharmaceutical manufacturer, we have the capacity to produce sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India offer specialized manufacturing services to the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier is proud to be a part of the Jubilant Pharma family. For more information, visit www.jublhs.com.

We are committed to enhancing value for our customers and stakeholders by providing innovative and cost-effective solutions, through sustainable growth, profitability, and strategic resource investments. If you’re ready for a rewarding challenge, we encourage you to take the first step and apply today!

Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity within our workforce. Our goal is to have a workforce as diverse as the patients and customers we serve. We foster an inclusive environment where employees can thrive, and where differences are welcomed. By embracing diversity, we create products that benefit our patients, our clients, and human health overall.

Position Purpose:

The Compliance Auditor I/II/III is a highly visible operational position within the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company complies with all cGMPs, including applicable regulations from Health Canada, FDA, EU, and other international standards. This is achieved through conducting internal audits. The incumbent is responsible for managing the Internal Audit and Supplier Audit programs for GMP, GDP, and GLP compliance, working closely with operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent will also coordinate and develop a comprehensive Quality auditing strategy with GXP operational groups and Quality Systems.

Key Responsibilities:

Ensure Regulatory Compliance: Ensure that JHS meets regulatory agency expectations and customer requirements by auditing and monitoring key suppliers providing materials or services used in GMP activities. The Compliance Auditor will achieve this by performing audits and monitoring to assess compliance with current GMP regulations, as well as Jubilant policies, directives, and procedures.
Audit Program Development and Execution:
- Develop, maintain, and execute the Internal and Supplier Audit Program, conducting GXP audits in accordance with the audit schedule.
- Create and implement a systematic approach to conduct all audits, presenting findings and recommending changes to procedures or practices that do not comply with stated regulations.
- Manage the Internal Audit and Supplier qualification programs, including audit schedules, SOPs, the Approved Supplier List (TrackWise PR records), and Supplier Quality Agreements.
- Plan audit scope and schedules with internal departments and suppliers by creating audit plans and identifying internal resources to assist with audits, when applicable.
- Issue audit observations and reports on time, requiring minimal revisions from approvers.
- Review and evaluate responses to Internal and Supplier audits to determine the acceptability of responses and CAPA plans. Follow up on CAPA implementation to ensure effective resolution and documentation of issues in the approved audit tracking system.
- Lead audits for specific causes when necessary, such as addressing critical audit findings, fraud, or misconduct related to suppliers or internal processes.
- Report metrics to Site, Department, and Corporate Quality management.
Regulatory Inspection Support: Assist with facility readiness for Regulatory Inspections, support site operations during regulatory and third-party inspections, and serve as co-host when required, participating in related tasks.
Additional Responsibilities:
- Complete department-related Change Controls, CAPAs, and Deviations as needed.
- Participate in cross-functional improvement projects related to audit compliance, supplier qualification, and other quality-related topics within the organization.
- Review and approve component specifications and SAP source lists.
- Support compliance efforts and represent QA on projects related to new suppliers or materials.

Required Qualifications:

Auditor I:

Bachelor’s degree in a professional, technical, or life sciences field, or equivalent combination of education and experience.
CQA or equivalent certification preferred, but not required.
At least two (2) years of experience in a Pharmaceutical or FDA-regulated environment required.
Experience in aseptic pharmaceutical manufacturing is desirable.
Extensive knowledge of quality systems and experience in conducting internal and supplier audits.
Familiarity with regulatory authorities and/or regulatory inspections is a plus.
Knowledge of regulations such as Health Canada, FDA, EU, ISO, and other applicable guidance documents.
Proficiency in Microsoft Word and Excel required.
Proficient in Microsoft Office (Word, Excel, PowerPoint), and experience with SAP and TrackWise.
Potential travel requirement: 10% to 40%.

Auditor II:

Bachelor’s degree in a professional, technical, or life sciences field, or equivalent combination of education and experience.
CQA or equivalent certification preferred, but not required.
At least five (5) years of relevant experience, including at least two (2) years in a Quality Unit.
At least two (2) years of experience in a Pharmaceutical or FDA-regulated environment, including experience with aseptic pharmaceutical manufacturing.
Extensive knowledge of quality systems and experience in conducting internal and supplier audits.
Experience with regulatory authorities and/or regulatory inspections is desirable.
Knowledge of regulations such as Health Canada, FDA, EU, ISO, and other applicable guidance documents.
Proficiency in Microsoft Word and Excel required.
Proficient in Microsoft Office (Word, Excel, PowerPoint), and experience with SAP and TrackWise.
Potential travel requirement: 10% to 40%.

Auditor III:

Bachelor’s degree in a professional, technical, or life sciences field, or equivalent combination of education and experience.
Certified Quality Auditor or equivalent certification required.
At least ten (10) years of relevant experience, including at least five (5) years in a Quality Unit.
At least five (5) years of experience in a Pharmaceutical or FDA-regulated environment, including experience with aseptic pharmaceutical manufacturing.
Extensive knowledge of quality systems and experience in conducting internal and supplier audits.
Experience with regulatory authorities and/or regulatory inspections is desirable.
Knowledge of regulations such as Health Canada, FDA, EU, ISO, and other applicable guidance documents.
Proficiency in Microsoft Word and Excel required.
Proficient in Microsoft Office (Word, Excel, PowerPoint), and experience with SAP and TrackWise.
Potential travel requirement: 10% to 40%

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Compliance Auditor I/Ii/Iii

Job Description

What We Offer:

Position Purpose:

Key Responsibilities:

Required Qualifications:

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