Title: Quality Assurance Analyst
Position: Direct Hire, Hamilton NJ
Our Quality Control and Assurance Analyst 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 functional department to assure that the company is compliant with all industry standards for quality assurance.
- 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) and generating CAPA reports.
- Plan annual internal and vendor audit schedules, conduct audits, and complete audit reports.
- 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.
- Five (5) years' industry related experience, including at least four (4) years’ experience with Good Clinical Practice (GCP) in the pharmaceutical/clinical research industry.
- Must have a minimum of three (3) years' quality assurance with evidence of increasing responsibility.
- Practical knowledge for Good Clinical Practice (GCP) required.
- Must have familiarity and experience with FDA audit preparation and hosting.
- Experience with developing CAPA reports 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 as well as with Windows, Word, Excel, PowerPoint, and Access.
- Bachelor's degree is required.
- Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
Hp Quality Centers
Hp Quicktest Professional