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Associate, QA ComplianceJubilant HollisterStier LLC • Spokane, Washington, United States
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Associate, QA Compliance

Jubilant HollisterStier LLC
  • US
    Spokane, Washington, United States
  • US
    Spokane, Washington, United States
Postuler Maintenant

À propos

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.
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.
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 QA Compliance Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities.
Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs / Policies, Specifications and related guidelines / regulations.
Accountable for facilitating Deviations investigation / resolution, assessing product impact and for completing / writing final assessment / lot disposition for QA Management and Client review and approval.
Enters data into database in support of the corporate RCA and CAPA activities.
Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
Interface with management and responsible individuals to assure task completion on or before established due dates.
Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc.) to assure compliance and product quality and safety.
Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
Provide Deviations and CAPA metrics as needed in support of management review of system data.
Work extensively with appropriate department(s) to gain an understanding of the production / analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Qualifications
Associate's Degree in Biology, Chemistry or related field required.
Bachelor's Degree in a science field desired.
Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
5 years of experience may be used in lieu of an associate's degree.
Sologic Certificate desired.
Pharmaceutical and FDA regulated industry experience desired.
Experience with technical writing, investigations, CAPA systems, building & manufacturing processes / systems, and QC analysis is highly desired.
Direct or supporting aseptic manufacturing experience in bio / pharma industry desired.
Microsoft Word & Excel required.
Knowledge of cGMPs desired.
Basic exchange of information required.
Managing conflict and influencing outcomes desired.
Provides analysis, diagnosis or production tasks which noticeably impact end results.
Location Spokane, WA - On Site, Full-Time
Shift Monday-Friday | 8:00 AM - 5:00 PM
Compensation & Benefits Hiring Wage: $58,047.50 - $78,494.46, with opportunities for growth, promotion, and annual raises.
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
EEO/AA Employer 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.
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.
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  • Spokane, Washington, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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