QA Lead Auditor

Synergy Bioscience, Inc.

United States

United States

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QA Lead Auditor – With Previous FDA Audit Experience This position will be responsible for planning and conducting audit procedures, including identifying and defining audit issues, developing audit criteria, reviewing and analyzing evidence, documenting the status and operating procedures of the organization, and preparing audit reports. The Lead Auditor will be responsible for the assessment of the organization’s quality system and compliance status in accordance with all relevant regulations and guidelines, such as 21CFR Parts 211, Parts 600s, Parts 3 & 4, as well as Part 820. The lead auditor will independently perform quality audits of drug product manufacturing practices to ensure products, controls, procedures, and processes meet quality standards. The Lead Auditor will also prepare audit reports and communicate findings to stakeholders.
Responsibilities
Perform high‑profile audits for manufacturing facilities and clinical trial sites
Lead a team of auditors, conduct manufacturing site audits, and identify and follow up on any resolved audit findings identified during a Quality Assurance Audit
Adhere to all safety, environmental, and quality requirements, including Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, company policies, and other regulatory requirements
Schedule audit activities with internal sites and provide audit agenda
Write audit reports of findings, recommendations, and management corrective action plans
Ensure issues from sponsor audits are promptly communicated to the appropriate team
Track audit responses and auditees’ remediation CAPAs until completion and closeout
Independently perform evaluations of quality systems and practices to identify potential problems
Stay up to date on current FDA and Health Canada manufacturing trends
Education & Experience, Knowledge & Skills
Previous work experience with FDA or Health Canada Agencies is a requirement
Minimum of a BS degree in science with at least 5 years of experience in performing and discussing audits
Thorough knowledge of current standard practice and regulations
Ability to review technical documents
Location Hybrid work style with requirements to travel overseas to perform onsite audits.
Benefits
Exceptional hourly rates on 1099 or C2C
Reimbursement of all expenses while working on the project
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United States

Sprachkenntnisse

English

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