Overview

Software Engineer (Test Development Infrastructure, North Reading) Jobs in North Reading, MA at Teradyne

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We’re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan

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

This is a hybrid position that requires two days in the Paramus, NJ office a week.

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:

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.
Position may require approx. 10-15% travel (optional)

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/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.
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Title: Software Engineer (Test Development Infrastructure, North Reading)

Company: Teradyne

Location: North Reading, MA

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