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
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Skills Required
- Bachelor's degree or higher in a scientific discipline, or equivalent education and experience
- Two to three years of related technical experience and/or training
- At least two years of auditing experience in a GLP-regulated environment
- Professional certification such as RQAP-GLP, ASQ-CQA, or equivalent
- Proficiency with Microsoft Office Suite
- Legal authorization to work in the United States without current or future employer sponsorship
What We Do
Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
