Specialist, QA Auditor

Jubilant HollisterStier Spokane is an equal opportunity employer. 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. For our EEO Policy Statement, please click here. If you’d like more information on your EEO rights under the law, please click here. JOB DESCRIPTION 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 life-changing 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. 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 main function of the QA Auditor, Specialist & senior Specialist is to coordinate personnel to support the CMO & ABU production schedule. This person will work closely with peer training specialists to ensure compliance with cGMPs prior to assigning personnel to areas. The QA Auditor, Specialist is the department SME and will have in depth knowledge of area SOPs to help guide personnel throughout the production day. They are also expected to analyze, present and propose department processes and technologies to determine improvements to processes, equipment, and automation to optimize processes, meet present and new regulations, reduce waste, increase capacity, and develop and implement methods to increase output while complying with cGMP's. The QA Auditor Specialist will qualify to perform all QA Auditor tasks and processes. Complete inspector qualification program for manual and semi-automated inspection; qualification must be maintained annually. Process final container samples; perform inspection/sampling according to SOP, Protocol or client request memo. Read and follow established Standard Operating Procedures covering execution and documentation of QA Auditing processes. Complete accurate documentation of QA Auditing processes on production records using GDP. Assure that labeling and packaging lines are clean and free of materials and components from previous lots. Perform visual inspection of product vials and packaging over extended periods of time (12 hours/day, with appropriate breaks). Assure that through a system of auditing that cGMPs are followed in manufacturing and finished product packaging areas. Provide effective day-to-day leadership and oversight for small groups ranging in size from 5 to 10 team members. Schedule team members proficiently to achieve target turnaround times and meet production schedule targets. Area SME for SOP updates and proposed equipment/process changes. Partner with training peers to drive training of team members. Write clear, concise memos for associated tasks. Train or schedule training for Auditors. Fluent in: SAP, Trackwise, MasterControl, ComplianceWire. Initiate/complete deviations, CAPAs, Change Controls per the applicable SOPs. Participate in RCAs, CAPAs, Change Controls, and other process improvements. Provide backup for QA Supervisor as required. Qualifications: High school diploma or equivalent required. Associate of Science required; bachelor’s degree desired. Minimum 5 years related experience required (with no degree). Minimum 3 years related experience required with an Associate's degree. 2 years’ experience required with a Bachelor's degree. Electronic documentation management system and/or LMS experience required. Pharmaceutical experience desired. FDA regulated Industry Experience desired. Visual Inspection Qualification knowledge desired. Lead experience desired. Basic exchange of information. Managing conflict and influencing outcomes. Service oriented. Experience with training in corporate environments. Understanding of CFR21, GDP, cGMP, ISO desired. This position requires the basic understanding of pharmaceutical manufacturing, problem solving skills, and interpersonal relations. Limited/elementary vocational knowledge required. Advanced/specialized knowledge of aseptic process/pharmaceutical manufacturing desired. Position requires cGMP and pharmaceutical manufacturing knowledge. Specifically, the Auditor must be able to recognize deficiencies in product quality and report these to the appropriate supervisor(s). The Auditor must have a thorough understanding of the QA and manufacturing systems as related to the testing and Packaging operation and batch records. Other Physical requirements: Ability to lift 40 pounds unassisted, prolonged sitting and standing, manual dexterity, repetitive activity (Data Entry). Routine environment with simple rules and detailed instructions. Managing conflict and influencing outcomes desired. Differing situations: search for solutions or new applications desired. Ability to identify problems and effectively seek solutions. Location: Spokane, WA — On Site, Full-Time Shift: Monday-Friday | 8:00AM-5:00PM Compensation & Benefits That Start on Day One — Because Your Well Being Matters Hiring Wage: $64,477.98 – $87,228.27, 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: 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: 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: View email address on click.appcast.io 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. #J-18808-Ljbffr