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Quality Assurance Auditor II

Altasciences Preclinical Services Everett ,WA
  • Posted: 23 days ago
  • Full-Time
Job Description
Everett, WA, USA Req #977

The Quality Assurance Auditor coordinates auditing activities to ensure compliance with SOPs and GLP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training
programs, data and documentation reviews.

Responsibilities:
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  • Audits protocols, amendments, raw data, reports and supporting documentation for internal accuracy, consistency, and conformance with regulations and internal SOPs
    Performs phase inspections of ongoing study activities
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  • Performs facility audits to ensure departmental compliance with the regulations
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  • Oversees and assists with audits to assure departmental consistency
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  • Prepares, issues, and tracks reports of observations noted during audits and inspections
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  • Applies a thorough understanding of compliance to a broad range of regulatory issues
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  • Maintains computerized files to support audit activities
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  • Assists in scheduling audits and assigning resources to projects
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  • Coordinates auditing activities and implements auditing systems to ensure compliance with GLP requirements
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  • Identifies, evaluates, and implements best practices
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  • Evaluates interdepartmental processes for improvement opportunities and proposes solutions
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  • Helps design and develop risk-managed regulatory processes
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  • Oversees and designs training systems; acts as a lead trainer for new and junior staff
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  • Drives project planning and implementation; acts as lead auditor on studies
    Solicits and gains support of employees, clients and management through effective collaboration and negotiation; represents QA in workgroups
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  • Evaluates interdepartmental processes for improvement opportunities and proposes solutions
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  • Oversees and designs training systems; trains and qualifies trainers on internal processes and procedures
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  • Communicates with clients regarding regulatory issues
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Requirements:
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  • Bachelor's degree (B. S.) in a scientific discipline, or equivalent combination of education and experience
    Two to three years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment
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  • Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor) or other certification is recommended
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/Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS,Seattle, WA and Philadelphia, PA.

Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

Altasciences uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.E-Verify.gov.

Other details
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  • Pay Type Salary
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  • Required Education Bachelor's Degree
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  • Job Start Date Monday, October 5, 2020
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  • Everett, WA, USA
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Altasciences Preclinical Services

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