Specialist, QA OversightJubilant Pharma, LLC • Spokane, Washington, United States
Specialist, QA Oversight
Jubilant Pharma, LLC
- Spokane, Washington, United States
- Spokane, Washington, United States
À propos
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.
Job Description 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.
The QA Oversight Specialist plays a critical role in ensuring that all manufacturing and quality control operations meet established quality standards and regulatory requirements. This position provides daily on‑the‑floor support to all functions associated with Manufacturing and Quality Control, serving as a key liaison between operational teams and the Quality Assurance department. The specialist is responsible for the evaluation and review of ongoing operations, ensuring compliance, consistency, and continuous improvement across all quality‑related activities. This includes oversight of facility operations, systems, and manufacturing support functions such as Metrology, Engineering, Maintenance, and Information Systems (IS).
Essential Responsibilities
Regulatory Compliance Ensure all procedures and practices within Manufacturing and Quality Control align with applicable US and European regulatory standards.
On‑the‑Floor Oversight Conduct real‑time oversight of Manufacturing and QC operations while in controlled aseptic environments to verify that products meet labeling, dating, and packaging requirements per SOPs and cGMP.
Observation and Reporting:Provide daily, weekly, and monthly summaries of floor observations, respond to findings, and ensure timely completion of corrective actions.
Problem Identification and Mitigation: Recognize potential quality issues, review and approve mitigation strategies, and collaborate with department supervisors to resolve deficiencies in product quality or systems.
Deviation Investigation: Ensure investigations into facility or support system deviations are thorough, accurate, and adequately documented.
Independent and Collaborative Problem Solving Demonstrate the ability to solve complex problems both independently and within cross‑functional teams.
Aseptic Processing Oversight: Provide QA oversight for aseptic processing while present within controlled environment to ensure sterility and compliance. Obtaining and maintaining access to controlled environment is required.
Training Support: Assist in onboarding and training new QA Oversight personnel to maintain consistency and quality standards.
Quality System Review: Review and approve quality system records, ensuring accuracy and regulatory compliance.
Continuous Improvement: Proactively revise SOPs related to job functions to align with evolving industry standards and best practices.
On the floor batch record review: Perform daily review of on the floor manufacturing batch records to ensure compliance with ALCOA++ principles.
Ability to don sterile gowns.
Qualifications
Bachelor of Science degree or 4 years of technical manufacturing experience in lieu of degree required.
Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience required.
FDA‑regulated industry required.
Proficiency in Microsoft Word, Excel and PowerPoint required.
Mechanical aptitude desired.
In‑depth understanding of the relationship between regulatory requirements, operating procedures, and ensuring compliance in a production environment required.
Able to follow detailed instructions required.
Excellent interpersonal skills required.
Able to navigate differing opinions required.
Problem‑solving skills required.
Other Physical Requirements
Exposure to allergens.
Working in aseptic areas.
Prolonged standing and sitting.
Location Spokane, WA — On Site, Full Time
Compensation & Benefits That Start on Day One Hiring Wage: $74,155.00 – $100,323.44, with opportunities for growth, promotion, and annual raises.
Starting on your first day, you receive:
Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
Life & AD&DD insurance
Short‑Term & Long‑Term Disability Insurance
Employee Assistance Program
Jubilant Hollister Stier 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.
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Compétences linguistiques
- English
Avis aux utilisateurs
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