Auditor II/III, Compliance

Jubilant Bhartia Group • Spokane, WA

108d • $77,968 - $113,900

About The Position

The Compliance Auditor II/III is a highly visible operational position of the Corporate Quality Compliance Team. The role of the Compliance Auditor is to ensure that the company is adhering to all cGMPs, including FDA and other applicable International Regulations, Guidance documents and Standards via performance of internal audits. The incumbent manages the Internal Audit and Supplier Audit Programs for GMP, GDP and GLP compliance, working closely with the operational functions to define and review processes, procedures, and systems to be audited annually. The incumbent coordinates and develops with GXP operational groups and Quality Systems a holistic Quality auditing strategy.

Requirements

• Bachelor's degree in related professional technical or life sciences degree/field or equivalent combined education and experience required.
• CQA or equivalent desired, but not required.
• Minimum five (5) years of related experience required, must include 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 the Code of Federal Regulations, EU guidance, ISO and other industry regulations.
• Knowledge and interpretation of GMPs and quality systems.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.
• Potential travel 10% - 40%.
• Requires use of personal protective equipment in designated areas.

Nice To Haves

• Minimum ten (10) years of related experience for Auditor III, must include Quality Unit experience.
• Minimum of five (5) years of experience within a Pharmaceutical or FDA-regulated environment required.

Responsibilities

• Ensures that JHS meets regulatory agencies expectations and customers' needs by auditing / monitoring key suppliers that provide material or services utilized for executing GMP activities.
• Responsible for the development, maintenance and execution of the Internal and Supplier audit program and conducting GXP audits in accordance with the audit schedule.
• Creates and executes a systematic approach to conduct all audits presenting findings and recommended changes to procedures or practices that are not in compliance with stated regulations.
• Manages and maintains the Internal Audit and Supplier qualification programs, including associated Audit schedules, SOP's, Approved Supplier List (TrackWise PR records), and Supplier Quality Agreements.
• Planning the scope and scheduling audit(s) with internal departments, and suppliers by creating an audit plan and identifying resources within Jubilant to assist with the audit.
• Issue audit observations and reports as per the required deadlines requiring minimal edits from the approver.
• Reviews and evaluates Internal and Supplier audit responses to determine acceptability of the response and any applicable CAPA plans.
• Performs follow up activity to ensure effective CAPA implementation that resolves and documents issues pertaining to the internal and supplier audits.
• Leads for-cause audits as required to address suspected critical audit findings, fraud, or misconduct related to suppliers, or internal processes.
• Reporting metrics to Site, Department and Corporate Quality management.
• Supports readiness of the facility for Regulatory Inspection.
• Assists site operations during regulatory and third party inspections, and serves as co-host when required.
• Completes department related Change Controls, CAPAs and Deviations as required.
• Works cross functionally on improvement projects related to audit compliance, supplier qualification and other quality-related subjects within the organization.
• Review and approve component specifications and SAP source lists.
• Support compliance efforts and represents QA on projects related to new suppliers or materials.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree