Senior QA Auditor

Altasciences•Everett, WA

2d•Hybrid

About The Position

At Altasciences, we are dedicated to assisting in the discovery, development, and manufacturing of new drug therapies to expedite their delivery to patients. As a Senior QA Auditor, you will conduct systematic and independent examinations (audits) of various study-related activities and documents. Your primary goal will be to ensure that these activities, along with the recording, analysis, and reporting of data, comply with the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11), and applicable regulatory requirements. You will be responsible for reporting findings to the Study Director, Responsible Person, and Testing Facility Management. Additionally, you will focus on building and maintaining effective working relationships across the organization and mentoring junior staff.

Requirements

Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
2-3 years of related technical experience and/or training.
A minimum of two years auditing in a GLP-regulated environment.
Well versed with Microsoft Office Suite.
Applicants must be legally authorized to work in the United States.
All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

Nice To Haves

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.

Responsibilities

Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
Audits all disciplines (examples of disciplines include Method Validations, Non-Clinical GLP Studies).
Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
Performs facility audits to ensure that the facility is in compliance with regulations.
Acts as lead auditor on studies and projects.
Maintains computerized files to support audit activities.
Supports project planning and implementation.
Provides risk-based compliance opinions and guidance.
Writes and issues inspection reports.
Works with internal clients to ensure that inspection findings are clearly communicated and understood.
Evaluates inspection finding responses to ensure they are written to address the findings appropriately.
Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced.
Identifies and communicates opportunities for process improvements based on audit and inspection observations.
Participates in and guides process improvement activities in both small intradepartmental groups as well as complex and possible multi-departmental interactions.
Maintains necessary documentation of QA records and study files.
Notifies management of observed quality and compliance trends in the areas inspected.
Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
Under supervision of a mentor/coach, performs interpretation of FDA regulations, project management, regulatory guidance review, quality issue investigations, and QA data collection, trending and analysis.
Recommends modifications in procedures to fit special needs or problems and involves manager when assistance in process improvement/resolution is necessary.
Interprets and can train on GLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
Carries out appropriate self-development efforts as directed.
Assists with regulatory training of staff.