Quality Assurance Associate

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.

Benefits

• 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

Perks

• Work-life balance
• Tuition reimbursement
• Opportunities for continuous learning and development
• Relaxed yet professional environment
• Professional membership fee reimbursement
• Exercise incentive program
• Charitable donation matching
• 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 summary reports for GLP studies Community involvement

Additional Duties and Tasks:

• May attend managerial and/or staff meetings where quality and compliance topics are discussed
• May attend SQA meetings or participate in webinars or on-line training resources to further continuing education
• Performs other duties as needed or assigned

Education and Experience Requirements:

• Associate or bachelor's degree in science, business or communication
• Working knowledge of MS Office suite (emphasis in Word and Excel)

Nice-to-Have

• 0-2 years of quality control or quality assurance and/or regulatory work experience is preferred
• Knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidance's (e.g., Bioanalytical Guidance documents) is preferred
• Knowledge of bioanalytical laboratory equipment, assays, techniques
• Knowledge of Good Documentation Practices
• An equivalent combination of education and experience or demonstrated ability may qualify the appropriate personnel for this position

Skills and Abilities Requirements:

• High level of attention to detail and skills in organization of records
• Ability to utilize appropriate mathematical concepts for interpreting scientific data
• Ability to apply reasoning skills to deal with a variety of situations and problem solving
• Skill in written and verbal communication
• Skill in customer service
• Ability to read and interpret protocols, procedures, regulations and guidelines
• Ability to travel occasionally for professional development

Physical Requirements:

• Position requires sitting over 2/3 of the time
• Position requires working in front of a computer monitor over 2/3 of the time
• Position requires walking less than 1/3 of the time between departments/offices
• Position requires standing less than 1/3 of the time
• Position requires talking or listening less than 1/3 of the time
• Position requires lifting up to 10 lbs. up to 2/3 of the time

About the Area

Located in a vibrant town and home to the University of Idaho, Moscow, Idaho is a friendly community with beautiful natural surroundings and a lively cultural scene. You'll enjoy walkable streets, live music, and access to some of the best outdoor recreation opportunities in the country. The Palouse area is made up of several neighboring towns, including Pullman, Washington, where you'll find a bustling college town environment with diverse dining options, events for everyone, and the Washington State University campus.

Community Involvement

Our goal is to build an enduring company of integrity in an environment that provides rewarding career paths and empowers individuals to engage in the well-being of the communities in which they reside. We seek to inspire the next generation of scientists through involvement of educational programs at every level. From making science fun for elementary-aged students, active participation in science fairs and guest lecturing at the undergraduate university level, we are stepping towards fostering a generation where science is exciting and an integral component of everyday life.

In addition to company support for community programs, Alturas offers employees paid time-off for individual volunteer activities and matching monetary donations to numerous 501(c)(3) organizations.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Compensation details: 46325-62675 Yearly Salary

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