Auditor II/III, Compliance

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, 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 the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

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

• 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. The Compliance Auditor accomplishes this by performing audits / monitoring in order to assess compliance to current GMP regulations, Jubilant policies, directives and procedures.
• Responsible for the development, maintenance and execution of the Internal and Supplier audit program and conducting GXP audits in accordance with the audit schedule including but not limited to:
  1. 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.
  2. 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, etc.
  3. 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, when applicable.
  4. Issue audit observations and reports as per the required deadlines requiring minimal edits from the approver.
  5. 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 in the approved audit tracking system.
  6. Leads for-cause audits as required to address suspected critical audit findings, fraud, or misconduct related to suppliers, or internal processes etc.
  7. 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 as well as participating in associated tasks.
• 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

Qualifications:

Auditor II:

• 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 required.
• Minimum Two (2) years of experience within a pharmaceutical/medical device or FDA regulated environment required.
• Extensive knowledge of quality systems and experience in conducting Supplier and Internal audits preferred.
• Experience with regulatory authorities and/or regulatory inspections desired.
• This position requires knowledge of the Code of Federal Regulations, EU guidance, ISO and other industry regulations. It also requires knowledge and interpretation of GMPs and quality systems. The applicant should be able to inspect and identify deficiencies in documents, products and processes required.
• Strong Knowledge of all applicable cGMP regulations and guidelines desired
• Ability to scope, assess and control risk desired
• Ability to reason logically, analyze and evaluate data and information and draw conclusions desired
• Understanding of the company operations and practices in the pharmaceutical industry desired.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and Track Wise required.
• Requires use of personal protective equipment in designated area.
• Potential travel 10% - 40% required

Auditor III: In addition to above

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

Shift: Weekday Days, Monday-Friday

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• • Auditor II: $81,800- $130,900 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
  • Auditor III: $89,300.00- $142,800 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

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

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