Alturas Analytics, Inc. located in beautiful Moscow, Idaho is seeking a full-time, on-site Quality Assurance Manager.

The Quality Assurance Manager responsibilities include:

• Performs analytical-based auditing activities as necessary and implements auditing systems to ensure compliance with GLP requirements
• Applies regulatory interpretation to a wide variety of work situations of increasing difficulty
• Leads and develops training of scientific and new QA staff
• Supervises activities of QA staff to ensure timely completion of tasks
• Represents the company through meetings and communications and interfaces with customers and regulatory officials
• 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 deficiencies and recommends changes for the laboratory to conform to SOP and regulatory standards and to improve efficiency
• Assists with development and/or reviews SOPs, Technical Procedures, Qualification Plans, and Validation Plans
• Acts as the host for regulatory agency inspections and client audits and formulates written responses to any findings

Education and Experience Requirements

• Bachelor’s degree or higher in a science related field or equivalent experience
• SQA RQAP-GLP or ASQ certification is preferred
• 7-10 years of quality control or quality assurance and/or regulatory work experience or an advanced educational degree
• Working knowledge of MS Office suite (emphasis in Word and Excel)
• Knowledge of bioanalytical laboratory equipment, assays, techniques is preferred
• Knowledge of Good Documentation Practices is required
• Knowledge of FDA Good Laboratory Practices (GLPs) and other FDA regulatory guidances (e.g., Bioanalytical Guidance documents) is required
• Knowledge of MHLW, OECD, ICH and other regulatory guidances preferred
• Knowledge of ISO9001 and/or investigative methods
• 1-3 years of supervisory experience
• 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 organization of records
• The ability to utilize appropriate mathematical concepts for interpreting scientific data
• Ability to read protocols, possess good writing and good oral communication skills
• The ability to apply reasoning skills to deal with a variety of situations and problem solving
• Skill in customer service
• Ability to interpret procedures, regulations and guidelines
• Ability to travel occasionally for professional development
• Ability to function effectively in stressful situations

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.

Alturas Analytics, Inc. is a bioanalytical laboratory providing 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. Our staff consists of talented and hard-working individuals who are dedicated to working with our collaborators to aid in the treatment and cure of disease.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• 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: One location

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