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Senior QA Auditor (GLP)

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Altasciences

9d ago

  • Job
    Full-time
    Junior & Mid Level
  • Quick Apply

AI generated summary

  • You need a Bachelor’s in a scientific discipline, 2-3 years of GLP auditing experience, relevant certification, and proficiency in Microsoft Office. On-the-job training will be provided.
  • You will conduct audits, maintain QA records, support compliance, evaluate findings, recommend process improvements, and assist with regulatory training and guidance.

Requirements

  • 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.
  • 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.

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 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 involve 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.

FAQs

What is the role of a Senior QA Auditor at Altasciences?

The Senior QA Auditor is responsible for conducting systematic and independent examinations of study-related activities and documents to ensure compliance with GLP regulations, SOPs, and applicable regulatory requirements. They report findings, mentor staff, and maintain effective working relationships across the organization.

What qualifications are required for the Senior QA Auditor position?

A Bachelor’s degree or higher in a scientific discipline, or an equivalent combination of education and experience is required, along with 2-3 years of related technical experience, including a minimum of two years auditing in a GLP-regulated environment.

Is professional certification recommended for this position?

Yes, professional certification such as RQAP-GLP or ASQ-CQA is recommended for the Senior QA Auditor role.

What types of audits will the Senior QA Auditor conduct?

The Senior QA Auditor will conduct audits of nonclinical and laboratory studies, including in-life audits, process audits, vendor qualifications, and facility audits to ensure regulatory compliance.

What tools or software skills are required for this job?

Proficiency in Microsoft Office Suite is required for the Senior QA Auditor position.

What training opportunities does Altasciences provide for this role?

Altasciences provides on-the-job training in performing audits, opportunities for independent reading, attendance at training seminars, and continual GLP training.

What benefits does Altasciences offer to employees?

Altasciences offers a variety of benefits, including health/dental/vision insurance plans, 401(k) with employer match, paid vacation and holidays, paid sick leave, and employee assistance programs.

Are there opportunities for professional development within this role?

Yes, the Senior QA Auditor position includes access to training and development programs, as well as participation in annual performance reviews.

How does Altasciences promote diversity and inclusion?

Altasciences is committed to attracting, developing, and retaining talented employees from diverse backgrounds and ensures equal opportunity for all qualified applicants without discrimination.

What is the company culture like at Altasciences?

The culture at Altasciences focuses on collaboration, quality and excellence, employee development, customer focus, respect, and integrity, fostering a passionate and supportive work environment.

Altasciences

Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.

Science & Healthcare
Industry
1001-5000
Employees
1992
Founded Year

Mission & Purpose

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!

Culture & Values

  • Respect

    We are open to differences of opinions and value different viewpoints. We treat each other, our customers, participants in our studies, and the research animals in our care with dignity.

  • Quality and Excellence

    We provide services and solutions of the highest quality, and pride ourselves on challenging the status quo. We strive to exceed expectations by truly giving our best at everything we do.

  • Integrity

    We are honest and uphold strong moral principles. We conduct our business with transparency and high ethical standards.

  • Customer Focus

    We actively partner with our clients. We listen, remain accessible, deliver on commitments, and maintain open channels of communication to build and nurture a lasting relationship based on trust.

  • Employee Development

    We provide leadership, encourage professional development, recognize individual and team contributions, and offer a stimulating, safe working environment.