Specialist, QA Oversight

Job Description

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.

• Evaluate and review ongoing operations, ensuring compliance, consistency, and continuous improvement across all quality-related activities.
  • 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: Obtain and maintain 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: 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
• Don sterile gowns

Location

Spokane, WA — On Site, Full-Time Shift: Monday-Friday | 8:00AM-5:00PM

Compensation & Benefits

Hiring Wage: $74,155.00 – $100,323.44, 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

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.