About This Role
This role supports lead auditors and audit liaisons in conducting, hosting, and reporting quality assurance audits. The QA Auditor performs specific audit tasks under the direct supervision of more senior QA staff, contributing to the overall quality assurance process within the company.
Responsibilities
- Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor
- Contact auditees to agree on audit dates
- Make appropriate entries in the QA database
- Perform data reviews and file audits as directed
- Enter and categorize audit/inspection findings in eQMS
- Solicit follow-up information and close audits/inspection findings in the QA database
- Review and approve Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans
- Support Investigators derogatory status management in the database
- Prepare and release guidance documents with compliance information
- Maintain the QA repository with compliance information for investigators with derogatory status
- Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe
- Review documents, identify and call operational staff to answer related questions
- Perform required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews, and copying and stamping documents for release to the auditors/inspectors
- Obtain a fundamental knowledge of current relevant GLP regulations, guidelines, and related auditing techniques
- Provide QA consultancy where possible
- Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle
Requirements
- 1 year of Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience
- Equivalent combination of education, training, and experience
- Knowledge of word-processing, spreadsheet, and database applications
- Considerable knowledge of GXP regulations and quality assurance auditing techniques
- Strong interpersonal skills
- Excellent problem-solving skills
- Effective organization, communication, and team orientation skills
- Ability to initiate assigned tasks and to work independently
- Ability to manage multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Nice to have:
