Senior QA Auditor

altasciences; Columbia Township (MO); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth Progr

Telework when applicable.

Job summary

Altasciences is seeking a Senior QA Auditor in the United States to perform systematic audits of study-related activities ensuring GLP compliance per SOPs and regulations. This role reports findings to the Study Director and Management, while mentoring junior staff and maintaining QA documentation.

The candidate will lead audits across disciplines, conduct in-life and facility audits, and provide risk-based guidance to improve processes.

Qualifications

• Bachelor-level or higher in a scientific discipline or equivalent.
• 2–3 years related technical experience and/or training; minimum two years auditing in a GLP-regulated environment.
• Professional certification such as RQAP-GLP or ASQ-CQA recommended.
• Proficient with Microsoft Office Suite; training in audits and inspections.
• On-the-job training plus regional/national meetings in Quality Assurance, regulatory affairs and validation.

Responsibilities

• Audits phases of nonclinical and laboratory studies, reports, and issues QA statements to ensure regulatory compliance.
• Audits all disciplines (e.g., Method Validations, Non-Clinical GLP Studies).
• Performs in-life, process, vendor qualifications, equipment and software validation audits.
• Conducts facility audits to ensure regulatory compliance.
• Acts as lead auditor on studies and projects.
• Maintains QA records and study files; supports project planning and implementation.
• Provides risk-based compliance opinions and guidance; writes and issues inspection reports.

Skills

Auditing in GLP environment

Regulatory compliance understanding

Mentoring/coaching

Education

Bachelor's degree or higher in a scientific discipline

Tools

Microsoft Office Suite

Job description

About The Role

The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.

What You'll Do Here

• 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 the following tasks: 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.

What You'll Need to Succeed

• Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.


• 2 - 3 years related technical experience and/or training. A minimum of two years auditing in a GLP-regulated environment.


• 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.


• Proficient with Microsoft Office Suite


• Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs. Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• 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 when applicable.

Altasciences' Incentive Programs Include:

• Training & Development Programs


• Employee Referral Bonus Program