Senior Auditor, Quality Assurance

4 weeks ago

Paramus, United States NS Pharma Inc Full time

Department

Location

Reports to

Status

Start Date

Compensation Senior Auditor, Quality Assurance

Quality Assurance

Paramus, NJ (Hybrid 2 days a week)

Senior Director, Quality

Exempt, Regular, Full-Time

ASAP

Competitive Job Summary

Responsible for, but not limited to the following under the guidance of the Quality Assurance Head and designees: SOP Administration, including writing, reviewing, and distributing SOPs. Document Reviews (e.g., Protocols, Informed Consents, Study Reports). Corrective and Preventive Action (CAPA) tracking. Conducting Internal and System Audits. Support Inspection Readiness activities. Support Training initiatives. Process Improvement activities. Providing regulatory guidance and support to dedicated study teams. Additional Activities may include: Those related to Quality Assurance activities within NS Pharma’s Quality Assurance systems. Support/Conduct of Investigator Site Audits, Vendor Audits, and CRO Compliance. Developing and executing System Audit Plans. Essential Duties and Responsibilities (Include but not limited to the following. Other duties may be assigned.)

Drafts new SOPs, and updates current SOPs. SOP Administration, which includes collecting comments on SOPs and distributing SOPs through Agatha, an automated system, and its associated training. Conducts document reviews of Protocols, Informed Consents, Study Reports, Internal Audit Reports, etc. Corrective and Preventive Action (CAPA) tracking. Provides guidance and assistance in the development of corrective action commitments and performs regular follow-up. Performs audits of investigator sites, vendors, departments, processes, and systems, both internally and externally against NS Pharma Standards and applicable regulatory requirements. Supports Health Authority Inspection training and preparedness. Takes an active role in Health Authority Inspections. Develops and conducts internal GxP training programs. Supports ongoing development and operation of the quality function and the GxP Quality Management System. Contributes to corporate quality related goals and objectives. Maintains current with industry expectations and provides guidance and assistance to ensure NS Pharma sustains effective and efficient systems in support of GCP operations. Supports the quality oversight of GxP activities to ensure patient safety and data quality. Gives technical guidance in the preparation of audit reports. Supervisory Responsibility

None Qualifications

Current knowledge of applicable regulations from FDA and international agencies. In depth knowledge in Clinical Audit processes. Strong experience in GCP Quality Systems. Experience in Investigations, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques. Experience with risk management principles and processes. Experience with change management principles and processes. Performs duties with minimal supervision. Manages complex situations and is effective in influencing compliance decision-making. Well-developed communication skills (verbal and written). Possesses a high level of maturity and character. Extensive acumen in problem solving, managing priorities and a commitment to quality and customer focus. Familiarity and understanding of a multicultural environment. Basic knowledge of MS Word, Excel, Powerpoint, etc. Education and/or Experience

B.S. or B.S./M.S. in Chemistry, Biology, or related fields. Minimum 3-5 years of auditing or diverse experience in the pharmaceutical industry or is able to demonstrate required skills and knowledge. The applicant for this position will be stationed in the Paramus, NJ office.

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