Auditor II, Compliance

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.
We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers - This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn't have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

Job Description: The Compliance Auditor II 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, Health Canada, ICH, EU and other applicable International Regulations, Guidance documents and ISO Standards via performance of internal and supplier audits. The Compliance Auditor II maintains the Internal Audit and Supplier Audit SOPs for evolving GMP compliance. The incumbent coordinates and develops with GXP operational groups and Quality Systems an annual Quality auditing strategy. The responsibilities may include the following tasks, knowledge, skills and other characteristics. (This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

The Compliance Auditor II will be responsible for executing and supporting audits across internal operations, and suppliers/vendors ensuring compliance with global regulatory requirements and ISO standards. This individual will also play a key role in strengthening audit program infrastructure, supporting audit reporting, and managing CAPA lifecycle activities.

• Perform GMP/GDP audits in accordance with the supplier/vendor and internal audit programs.
• Support regulatory inspections and ISO audits as necessary.
• Perform periodic "surprise" GMP Internal audits.
• Create and maintain annual schedules for internal and supplier/vendor audits.
• Author audit reports, issue observations and track audit responses to completion.
• Support the creation and execution of Quality Agreements with suppliers.
• Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities.
• Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures.
• Support other Quality department needs as identified by management.
• Collaborate cross-functionally with Quality and Operations teams
• Flexibility to travel 20-40% of the time.

External Interfaces:

• FDA, Health Canada, International Regulatory Agencies and ISO Registrars
• Clients
• Suppliers/Vendors

Internal Interfaces:

• Works cross-functionally with all internal departments as required.

Qualifications:

• Bachelor's degree in related professional technical or life sciences degree/field or equivalent combined education and experience required.
• Certified Quality Auditor (CQA) or equivalent certification desired, but not required.
• Minimum five (5) years of related experience. (Must include Auditing and Quality Unit experience within a Pharmaceutical/Medical Device or FDA-regulated environment.) required
• Experience in conducting Supplier and/or Internal audits required.
• Strong knowledge of applicable cGMP regulations and guidelines (Code of Federal Regulations, Health Canada Regulations, EU Regulations, ISO Standards and other industry regulations) required.
• Strong knowledge of pharmaceutical quality systems and ability to interpret GMPs required.
• Strong attention to detail and ability to readily identify deficiencies in documents, products and processes required.
• Ability to reason logically, analyse and evaluate data and information, and draw appropriate conclusions required.
• Understanding of company operations and practices in the pharmaceutical industry required.
• Ability to adapt quickly to shifting needs and/or priorities required.
• Able to interface well with all levels of personnel required.
• Excellent communications skills, both written and verbal and a high degree of professionalism required.
• Experience with regulatory authorities and/or regulatory inspections desired.
• Proficient in Microsoft Office software applications (Word, Excel, PowerPoint), working knowledge and experience with SAP and TrackWise.

Other Physical Requirements:

• Work is sedentary. No special physical demands required to perform this work.
• Requires use of personal protective equipment in designated areas.

Canada: No special physical demands are required to perform the work.

• The work is regularly performed inside an office environment with occasional visits to the radiopharmaceutical production area when conducting internal audits or hosting tours.
• In addition to the risks associated with radiopharmaceutical production, the work area involves the daily risks or discomfort requiring the application of the usual safety precautions in places such as offices, training and meeting rooms, etc. Safe work practices will be used to use office equipment and safe radioprotection practices will be used when in the production environment.

USA: Work is regularly performed inside in an office

• and in a manufacturing environment on occasion for the purpose of performing audits.
• The work area involves everyday risks or discomforts requiring normal safety precautions typical of such places as offices, meeting and training rooms, etc.
• As appropriate, employees are required to use personal protective equipment such as masks, gowns, booties, safety glasses, or gloves.
• Must exercise extreme safety and precaution at all times in all designated cGMP areas in the facility.

Communication Skills:

• Demonstrated technical writing skills with the ability to write clearly and concisely conveying the information precisely to the findings and recommendations required.
• Advanced level of written and oral communication skills with the ability to obtain, clarify, or give factual information, interpret instructions, and record data.
• Ability to build and maintain effective business partner relationships with varied levels of staff.
• Active listening skills demonstrating the ability to give full attention to what others are saying, understanding the points being made, and asking the appropriate questions during the audit process.

REASONING ABILITY:

• Demonstrated ability to apply independent judgment regarding what needs to be done based on standard choices required using logic and reasoning identify alternative approaches and/or conclusions.
• Ability to recognize the existence of and differences among easily recognizable situations with respect to information or transaction available.

ANALYTICAL SKILLS:

• Demonstrated analytical and interpretive skills with the ability to examine processes, identify assumptions, and gather details accurately.
• Ability to understand levels of potential risks and how to address those risks.
• Strong attention to detail.
• Ability to study/review complicated things and explain them

Location: Spokane, WA - On Site, Full- -Time

Shift: Days | Monday-Friday | 8:00AM-5:00PM

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage: $89,300.00 - $142,800.00 annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

If you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:

Careers - Jubilant HollisterStier

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration 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, contact:
JHS-TalentAcquisition@jubl.com

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.