Manufacturing QA Auditor

Job Description

Summary of the Position

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The Quality Assurance Auditor reports to the Supplier Quality and Compliance Manager. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified.

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Roles and Responsibilities

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• Manage audit planning, scheduling, and execute internal and external audits for Nutramax Laboratories to assess compliance to the regulations.
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• Audit external suppliers (CMO’s) and maintain the vendor qualification program including the Approved Vendor List in Qualityze
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• Manage external vendor(s) responsible for international audits
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• Manage the Nutramax supplier corrective action request program (SCAR).
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• Manage all documents relating to audits, vendors, and suppliers in a QMS (Qualityze)
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• Determine the level of risk of findings identified and follow up on corrective actions ensuring they address the short-term correction as well as the preventive action of the finding.
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• Develop and implement a performance tracking system and reporting of departmental compliance.
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• Prioritize work to ensure that audits and reports are completed in a timely manner. Support implementation of CAPA program where necessary.
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• Train and assist internal departments to understand and comply with Quality and Compliance expectations.
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• Assess internal audit process by identifying and prioritizing areas of the business where there is a risk of non-compliance and assist in development and/or execute processes or policies to reduce that risk.
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• Support training and readiness for regulatory inspections.
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• Provide support to other Quality Assurance team members.
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• Report audit metrics to Quality Assurance and department management.
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• Communicate effectively with all levels of the organization and departments within the organization and function within a team environment.
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• Understand the roles and responsibilities of the Contract Manufacturing Organizations and provide Quality Assurance support for product development, investigations, and CAPAs as required.
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• Familiar with QA functions in SAP.
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• Perform other assigned duties as may be required in meeting Quality Assurance and company objectives.
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Minimum Requirements

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• Must have a minimum of 5 years of Quality Assurance auditing experience in cGMP environment with a minimum of 5 years of external vendor/ supplier compliance auditing experience within an FDA regulated industry.
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• Knowledge of the Regulations 21CFR Part(s) 210, 211, 507 as well as the Dietary Supplement Regulations 21 CFR 111 is required.
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• ASQ Certified Auditor (CQA) Certification is preferred.
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• Must be proficient in Computer Software applications including MS office suite.
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• Must be able to stand, walk, push, and pull in a variety of environments including a Manufacturing and clean rooms. Must have the ability to wear all required Personal Protective Equipment (PPE) based on the auditing environment. Must be able to travel 20 – 30% for domestic audits, (International travel may be needed per quality management).
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Education and Experience: B.A. or B.S. in Science or Technical field required.

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Supervisory Responsibilities: None