Specialist, QA Oversight

About the Role

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).

Responsibilities

• Ensure all procedures and practices within Manufacturing and Quality Control align with applicable US and European regulatory standards.
• 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.
• Provide daily, weekly, and monthly summaries of floor observations, respond to findings, and ensure timely completion of corrective actions.
• Recognize potential quality issues, review and approve mitigation strategies, and collaborate with department supervisors to resolve deficiencies in product quality or systems.
• Ensure investigations into facility or support system deviations are thorough, accurate, and adequately documented.
• Provide QA oversight for aseptic processing while present within controlled environments to ensure sterility and compliance.
• Assist in onboarding and training new QA Oversight personnel to maintain consistency and quality standards.
• Review and approve quality system records, ensuring accuracy and regulatory compliance.
• Proactively revise SOPs related to job functions to align with evolving industry standards and best practices.
• Perform daily review of on-the-floor manufacturing batch records to ensure compliance with ALCOA++ principles.

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 experience 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.

Physical Requirements

• Exposure to allergens.
• Working in aseptic areas.
• Prolonged standing and sitting.
• Ability to don sterile gowns.

Location

Spokane, WA — On-Site, Full-Time

Schedule

Monday-Wednesday, Every Other Thursday | 6:00 PM-6:00 AM

Pay

Hiring Wage: $74,155.00 – $100,323.44, with opportunities for growth, promotion, and annual raises.

Benefits

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

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