QA Lead Auditor

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:

·       Able to perform high-profile audits for manufacturing facilities and clinical trial sites.

·       Lead a team of auditors, conduct manufacturing sites audits, and identify and follow up on any resolved audit findings identified during a Quality Assurance Audit.

·       Adheres to all safety, environmental, and quality requirements, not limited to: Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

·       Schedules audit activities with the internal sites and provide audit agenda.

·       Writes audit reports of findings, recommendations, and management corrective action plans.

·       Assure that issues from sponsor audits are promptly communicated to the appropriate team

·       Tracks audit responses and auditees’ remediation CAPAs until completion and closeout.

·       Independently performs evaluations of quality systems and practices to identify potential problems

·       Stays 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 a minimum of 5+ years of experience in performing and discussing audits.

·       Thorough knowledge of current standard practice and regulations

·       Ability to review technical documents

This unique opportunity provides:

·       Exceptional hourly rates on 1099 or C2C.

· Reimbursement of all expenses while working on the project.

Requirements

Education & Experience & Knowledge & Skills:

·       Previous work experience with FDA regulations and GMP requirements is required.

·       Minimum of a BS degree in science with a minimum of 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

This unique opportunity provides:

·       Exceptional hourly rates on 1099 or C2C.

· Reimbursement of all expenses, while working on the project.