Senior QA Auditor (HYBRID)

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Columbia Township (MO)

Hybrid

USD 70,000 - 110,000

Full time

14 days+

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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

Telework when applicable.

Training & Development Programs

Employee Referral Bonus Program

Job summary

Altasciences is seeking a Senior QA Auditor to perform independent audits of study-related activities and documents to ensure data integrity and compliance with GLP, 21 CFR Part 58 and Part 11, SOPs, and applicable regulations. The role includes mentoring staff and reporting findings to management.

The position requires a science degree, 2–3 years of GLP auditing experience, and familiarity with FDA regulations. Telework when applicable and a comprehensive benefits package are offered.

Qualifications

Bachelor’s degree or higher in a scientific discipline or equivalent experience.
2–3 years related technical experience; minimum two years auditing in GLP environment.
Certification such as RQAP-GLP or ASQ-CQA is recommended; not required.

Responsibilities

Audits phases of nonclinical and laboratory studies, reports, and related duties to ensure regulatory compliance.
Audits all disciplines (e.g., Method Validations, Non-Clinical GLP Studies).
Performs in-life, process, vendor qualification, equipment and software validation audits.

Skills

Auditing

Regulatory knowledge

Microsoft Office

Education

Bachelor's degree in science

RQAP-GLP / ASQ-CQA (recommended)

Tools

GLP Regulations

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: