Job description

Alturas Analytics, Inc. a bioanalytical laboratory dedicated to supporting the pharmaceutical drug candidates from discovery through late phase clinical trials. Our vision: supporting transformative medicines for a healthier future.

We are seeking a Quality Assurance Manager to help ensure the quality and safety of our research.

More specifically, we provide expert GLP and Non-GLP LC-MS/MS and GC-MS/MS quantitation and PK/TK analytical services in both small and large molecules. We are a growing, privately-owned CRO specializing in method development, validation, and sample analysis in all biological matrices in support of therapeutic development programs.

Location

We are located in Moscow, Idaho, a vibrant college town that serves as the home of University of Idaho and a mere 10-minute drive from Washington State University in nearby Pullman. With its friendly community, beautiful natural surroundings, and lively cultural scene, Moscow is the perfect place to call home. You'll enjoy walkable streets, live music, and access to some of the best outdoor recreation opportunities in the country. (For consideration, Moscow’s cost of living and housing prices are much lower than Boise’s.)

Benefits

We have a relaxed yet professional environment. We strive to be a part of our community as well as a part of each other's lives through parties and monthly catered lunches as well as volunteering at local schools and events. We’re growing and doubling our lab capacity in the next year, so promoting from within and offering leadership development opportunities are top priorities. We pay 100% of your premiums for health insurance, dental, vision, life and short- and long-term disability. We also have paid vacation and holidays, a Safe Harbor 401K with an automatic 3% employer contribution, and a bonus program based on company-wide goals.

About the Role

The Quality Assurance Manager will work with Senior Staff and Test Facility Management to set the strategic direction of the Quality Assurance Unit and anticipate future QA needs. You will perform analytical-based auditing activities as necessary and implement auditing systems to ensure compliance with GLP requirements. As the Quality Assurance Manager, you will perform a wide variety of activities to ensure compliance with applicable regulatory requirements, apply regulatory interpretation to a wide variety of work situations of increasing difficulty, and lead and develop training of scientific and new QA staff.

Education and Experience Requirements (If you meet most but not all of our requirements, we will encourage you to apply.)

• Bachelor’s degree or higher in a science related field or equivalent experience
• Knowledge of Good Documentation Practices
• Knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidances (e.g., Bioanalytical Guidance documents)
• 7-10 years of quality control or quality assurance and/or regulatory work experience or an advanced educational degree
• 1-3 years of supervisory experience
• Working knowledge of MS Office suite (emphasis in Word and Excel)

Nice to Have

• SQA RQAP-GLP or ASQ certification
• Knowledge of bioanalytical laboratory equipment, assays, techniques
• Knowledge of MHLW, OECD, ICH and other regulatory guidances preferred
• Knowledge of ISO9001 and/or investigative methods

Job Responsibilities

• Perform analytical-based auditing activities such as: inspections and audits of study-based protocols, plans, in-process activities, data, test methods, etc.
• Help us continuously improve by assisting with development and/or review SOPs, Technical Procedures, Qualification Plans, and Validation Plans.
• Issue inspection and audit reports to report deficiencies and recommend changes for the laboratory to conform to SOP and regulatory standards and to improve efficiency.
• Implement auditing systems to ensure compliance with GLP requirements.
• Apply regulatory interpretation to a wide variety of work situations that require your technical expertise in problem solving.
• Lead, supervise, and develop training of scientific and QA staff.
• Communicate with internal and external stakeholders with integrity and accuracy.
• During regulatory agency inspections and client audits, you will act as host and formulate our written responses to any findings.

Please submit cover letter and resume to be considered. For complete job description and information about our company, please visit our website:

https://alturasanalytics.com/company/careers/

Relocation assistance may be available. Must be able to commute to Moscow, Idaho.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Moscow, ID 83843: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Work Location: In person

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