Quality Assurance Associate

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We are looking for a Quality Assurance Associate to join our team. The ideal candidate is detail-driven and passionate about compliance and regulations. As a Quality Assurance Associate, you will play a vital role in maintaining top-quality standards across our lab. You'll conduct audits, review records, support inspections, and help ensure everything meets SOPs and FDA regulations. If you're ready to make an impact behind the scenes, we want to hear from you!

Salary: Starting at $46,325, DOE

This position is on-site in Moscow, Idaho.

About Us

Alturas Analytics, Inc. is a contract research organization, bioanalytical laboratory providing personalized MS/MS bioanalytical services to the pharma and biotech industries worldwide. We are a growing, privately owned company working with our collaborators to aid in the treatment and cure of disease.

Joining the Alturas team means becoming a part of a supportive and passionate community. Our staff consists of talented, dedicated individuals who are committed to delivering the highest quality of service to our clients. Our goal is simple – to ensure that Alturas employees thrive so that we can do the best possible work in our field, ensuring greater care for our world.

• We pay 100% of your premiums for health, dental, and vision insurance and 25% of the premium for dependent coverage
• Paid time off (starting at 3 weeks/year) and paid holidays
• Bonus program based on company-wide goals
• Health Savings Account (HSA) (with company match) and Flexible Spending Account (FSA) options
• Life insurance and short- and long-term disability at no cost to you
• Safe Harbor 401k with an automatic 3% employer contribution
• Employee Assistance Programs focused on mental health
• Voluntary Life, AD&D, Critical Illness and Accident insurance
• Work-life balance
• Opportunities for continuous learning and development
• Relaxed yet professional environment
• Professional membership fee reimbursement
• Paid time off for volunteering
• Monthly catered lunches, holiday celebrations, unlimited (good) coffee, beverages, snacks and more!

Position Summary:

The Quality Assurance (QA) Associate is responsible for executing review, inspection, and audit procedures for materials submitted to the Quality Assurance Unit (QAU) for evaluation of compliance to procedures and regulations.

Essential Duties and Tasks:

• Provides assistance to the QAU management and other staff members to fulfill the QAU responsibilities designated by SOPs including but not limited to study audits, facility inspections, audits of logs and records, and archived materials
• Performs inspections and audits of study-based protocols, plans, in-process activities, data (paper or electronic), test methods, and a variety of reports and issues inspection and audit reports
• Reports compliance deficiencies to the QAU management and Test Facility Management and recommended actions to conform to SOP and regulatory standards
• Recommends changes to QAU management and Test Facility Management for the laboratory to conform to SOP and regulatory standards and to improve efficiency
• Performs inspections and audits of non-study-based documents and records associated with qualification and validation events and issues inspection and audit reports
• Generates and maintains a QAU copy of the Master Schedule
• Works laterally with scientific staff to assure the facility and operations meets standards set by Alturas procedures and FDA regulations
• Performs periodic and routine inspections and audits of facilities, systems and processes according to SOPs
• Drafting or review of Quality Assurance Statements for interim and final reports
• Signs a Quality Assurance Statement for interim and final reports
• Updates databases utilized by the QAU including those for project management
• May assist and participate in Sponsor audits and regulatory agency inspections as directed by the QAU management
• Assists with hosting customer and regulatory audits
• Assists with preparing periodic Study Status Reports to Study Directors and Test Facility Management and sending to off-site Study Directors and clinical study contacts as necessary
• May issue off-site Study Director status and…