Overview
QA Auditor Jobs in Everett, Washington, USA at Altasciences
Join to apply for the Preclinical GLP QA Auditor role at Altasciences
At Altasciences, we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part, and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we foster a passionate and collaborative work environment.
We are looking for talented and enthusiastic people to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
About
The Role
The QA Auditor reports to the QA Supervisor. This individual is responsible for carrying out systematic and independent examinations (audits) of trial-related activities and documents to ensure compliance with protocols, SOPs, GxPs, and regulatory requirements. They report findings to the Internal Study Team and management, and build effective working relationships across the organization.
What You’ll Do Here
Audit phases of laboratory and clinical studies, reports, and related duties to ensure regulatory compliance.
Audit all disciplines, including Screening, Recruiting, Clinical Operations, Laboratory, SRA, Data Services.
Perform in-life audits, process audits, vendor qualifications, equipment and software validation audits.
Write and issue inspection reports, communicate findings, and evaluate responses.
Ensure SOPs are current and followed during inspections.
Identify and communicate opportunities for process improvement based on audit observations.
Maintain documentation of QA records and study files.
Notify management of quality and compliance trends.
Perform SOP QA review, client hosting, regulatory agency hosting, and external test site/clinical site/bioanalytical laboratory qualifications under supervision.
Recommend procedural modifications and interpret GCP, GLP, GCLP, and related regulations.
Prepare for RQAP-GCP and/or RQAP-GLP certification.
Engage in self-development efforts as directed.
What You’ll Need To Succeed
Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, or a related field, or equivalent experience in the pharmaceutical industry.
What We Offer
The estimated pay range is $64K – $85K annually, varying based on experience, skills, education, and location.
Benefits (Regular Employees)
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework opportunities where applicable
Incentive Programs
Training & Development Programs
Employee Referral Bonus Program
Altasciences is an equal opportunity employer committed to diversity and inclusion. We welcome applicants from diverse backgrounds and provide reasonable accommodations during the recruitment process. Join us at Altasciences!
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Title: QA Auditor
Company: Altasciences
Location: Everett, Washington, USA
Category: Healthcare, Quality Assurance – QA/QC (Data Analyst)
