Quality Assurance Auditor I

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Job description

Description:

Salary: From $53,000 per year

Join our team as a Quality Assurance Auditor I and be part of a dynamic environment where your skills and expertise in GLP and GCP are valued. As a QA Auditor I, you will play a crucial role in ensuring compliance with GLP requirements through study audits, facility inspections, and regulatory compliance activities. In this role, you will collaborate across departments to ensure regulatory compliance, providing valuable insights and guidance on complex issues. Excellent writing and communication skills are essential, as you will be the bridge connecting various teams and fostering a culture of quality and compliance.

The ideal candidate will be adaptable and responsive to the ever-evolving regulatory landscape, thriving in a team-oriented environment. If you are a proactive problem-solver with GLP or GCP experience, we invite you to apply!

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 Analytics 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
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options
• Life insurance and short- and long-term disability at no cost to you
• Paid time off
• 7 paid holidays
• Safe Harbor 401k with an automatic 3% employer contribution
• Employee Assistance Program focused on mental health
• Bonus program based on company-wide goals

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 QA Auditor I performs analytical-based auditing activities including study audits and facility audits to ensure compliance with GLP requirements. The position also performs a wide variety of activities to assure compliance with applicable regulatory requirements. The QA Auditor I can apply basic interpretation of regulations to most work situations.

Essential Duties and Tasks:

• Provides assistance to the QAU management and other staff members to fulfill the QAU responsibilities designated by 400 level 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, recommending actions to conform to SOP and regulatory standards, while also suggesting changes to improve efficiency and alignment with these standards
• 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
• Assists with development and/or reviews SOPs, Technical Procedures, Qualification Plans, and Validation Plans
• Drafts, reviews and signs Quality Assurance Statements for interim and final reports
• Updates databases utilized by the QAU including those for project management
• Assists with hosting regulatory audits and acts as the host for client audits and formulates written responses to any findings
• Assists with new employee and annual regulatory training under the direction of QAU management
• Approves and signs periodic Status Reports to Study Directors and Test Facility Management and clinical study contacts as necessary and issues off-site Study Director status and summary reports

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

Requirements:

Qualifications:

• Associates or Bachelors degree in science, business or communication, or an equivalent combination of education and experience, may qualify the appropriate personnel for this position
• 2-6 years of quality control or quality assurance and/or regulatory work experience
• Working knowledge of MS Office suite (emphasis in Word and Excel)
• Knowledge of Good Documentation Practices
• Knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidances (e.g., Bioanalytical Guidance documents)

Skills and Abilities Requirements:

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

Nice to have:

• Quality-related certification from SQA, ASQ, or equivalent
• Knowledge of bioanalytical laboratory equipment, assays, and techniques

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.

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