Description
Assist lead auditors/audit liaisons in conducting, hosting and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QA staff.
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.
- 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, and 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, reviewing documents, identifying and calling operational staff to answer related questions, and performing required administrative duties.
- Obtain 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.
Qualifications:
- Bachelor's Degree preferred.
- 1 year of Quality Assurance experience in a pharmaceutical, technical, or related area, including GXP and/or Quality Assurance 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, work independently, manage multiple projects, and establish and maintain effective working relationships with coworkers, managers, and clients.