Q² Solutions · 4 hours ago
Quality Assurance Auditor 1
Ithaca, NY
Full-time
Remote
Entry Level
$52K/yr - $86K/yr
1+ years exp
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Responsibilities
Assisting in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor.
Contacting auditees to agree on audit dates and make appropriate entries in the QA database.
Performing data reviews and filing audits as directed.
Entering and categorizing audit/inspection findings in eQMS.
Soliciting follow-up information and closing audits/inspection findings in the QA database.
Reviewing and approving Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans.
Supporting investigators with derogatory status management in the database, preparing and releasing guidance documents with compliance information, and maintaining the QA repository with compliance information for investigators with derogatory status.
Assisting 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.
Qualification
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Required
Bachelor’s Degree in a relevant field.
1 year of Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience.
Other equivalent combination of education, training, and experience may be accepted in lieu of degree.
Knowledge of word-processing, spreadsheet, and database applications.
Considerable knowledge of GXP regulations and quality assurance auditing techniques.
Strong interpersonal and problem-solving skills.
Effective organization, communication, and team orientation skills.
Benefits
Integrated benefits programs and resources to take care of our employees’ physical, mental, emotional, financial, and social well-being
Company
Q² Solutions
Q² Solutions is a leading drug discovery and development laboratory services organization.
1,001-5,000 employees
Funding
Current Stage
Late StageLeadership Team
Patrice Hugo
Chief Scientific Officer
Company data provided by crunchbase
