Senior Quality Assurance Auditor
sklifescienceinc· QA
About this role
Overview
The GMP Quality Assurance Auditor will report to the Director of the Quality Assurance Department.
This position will be focused on ensuring GMP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and/or participate in all GMP QA audit programs which include both internal and external GMP audits. This position will provide day to day support to cGMPs to manage CMOs, packaging and labeling vendors for clinical trials and commercial manufacturing.
Responsibilities
- Support in review, approval, and logging of Change Controls, Investigations, Deviations, Incidents, OOS and OOT reports
- Review CAPAs, root cause analysis and Investigations
- Support lead audit planning conduct and report on SKLSI Quality Assurance routine and non-routine audits of activities, data, internal facilities, and processes in GMPs to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements
- Support non-routine audits that will include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope
- Support other auditors in planning, conduct and reporting of audits
- Support in authoring, reviewing, and approving internal controlled documents (SOPs, Policies, Guidelines and Forms) and associated quizzes
- Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities
- Participate in regulatory inspections in core and supporting roles
- Proficient in computer software Word, Excel, Access, Power Point, etc.
Qualifications
- A minimum of a bachelor’s degree (or equivalent) is
- Expertise in additional compliance disciplines is
- Comprehensive knowledge of the drug development process, applicable regulations (GMP), R&D and commercial practices, and scientific and quality terminology is
- Knowledge of procedural and records management requirements in a regulated industry is preferred.Prior experience in a regulated medical industry (Pharmaceutical and/or CMO) is preferred
- Prior pharmaceutical and quality/compliance related experience is preferred.
Frequently Asked Questions
Is the salary disclosed for the Senior Quality Assurance Auditor position at sklifescienceinc?
The salary for this Senior Quality Assurance Auditor role at sklifescienceinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Quality Assurance Auditor position at sklifescienceinc located?
This Senior Quality Assurance Auditor role at sklifescienceinc is based in Paramus, NJ, US. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Quality Assurance Auditor role at sklifescienceinc full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Quality Assurance Auditor role in the QA department at sklifescienceinc.
Which team or department does the Senior Quality Assurance Auditor at sklifescienceinc belong to?
This Senior Quality Assurance Auditor position is part of the QA department at sklifescienceinc. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Quality Assurance Auditor position at sklifescienceinc?
Click the "Apply Now" button on this page. You will be redirected to sklifescienceinc's official application portal hosted on icims where you can submit your application directly.
When was the Senior Quality Assurance Auditor job at sklifescienceinc posted?
This Senior Quality Assurance Auditor position at sklifescienceinc was posted on Jun 11, 2024. Apply as soon as possible — early applications are often reviewed first.
Senior Quality Assurance Auditor
sklifescienceinc
You'll be redirected to sklifescienceinc's official application page on icims.