Our Software Quality Assurance Specialist will establish and maintain quality assurance standards and measures throughout the organization that comply with regulatory requirements and standards. This position is responsible for working with senior leadership to assure that the company is compliant with all industry standards for quality assurance and computer system validation.
- Create, review, and update SOPs based on operational/technical needs.
- Work with senior leadership and department heads to identify any needs for new SOPs.
- Develop training and evaluation for staff on SOPs.
- Cultivate and disseminate knowledge of quality assurance best practices.
- Conduct investigations of potential data quality and/or data integrity issues (CAPA).
- Ensures that applicable computerized systems remain in a validated, 21 CFR part 11 compliant status.
- Assist in the development of change control processes, practices, and guidelines for new and existing technologies.
- Plan annual internal and vendor auditschedules, conduct audits, and complete auditreports.
- Lead and prepare all aspects of external audits, providing auditors with all necessary documentation.
- Identify external audit requirements and mitigate any company risks to compliance.
- Provide support for internal and external audits, corrective actions, responses, and follow-up.
- Bachelor's degree is required.
- Master’s degree in a relevant discipline preferred.
- Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
- Five (5) years' industry related experience, including at least four (4) years’ experience with Good Clinical Practice (GCP) auditing in the pharmaceutical/clinical research industry.
- Must have a minimum of three (3) years' quality assurance with evidence of increasing responsibility.
- Practical knowledge of federal regulations governing human subject research (21 CFR part 11) and guidelines for Good Clinical Practice (GCP) required.
- Must have familiarity and experience with FDA audit preparation and hosting as well as familiarity with standards and processes for electronic system validation.
- Experience with developing CAPA reports preferred.
- Experience with study design and research best practices is required.
- Strong communication (written and oral), organization, and interpersonal skills and the ability to interact with staff, sponsors, and regulatory agencies needed.
- Proficiency with learning management systems (Compliance Wire a plus) as well as with Windows, Word, Excel, PowerPoint, and Access.
- Must be able to travel at least 30%; this will include travel between the Hamilton, NJ and New York, NY offices.