QA Analyst

Highly Competitive Salary
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Hamilton, New Jersey
Posting date: 12 Aug 2019

Proclinical is currently seeking a Quality Control and Assurance Analyst for a biotechnology company located in Hamilton, NJ. Successful candidate will establish and maintain quality assurance standards and measures throughout the organization that comply with regulatory requirements and standards.

Job Responsibilities:

  • 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.

Skills and Requirements:

  • BA/BS is required.
  • Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
  • 5 years' industry related experience, including 4+ years' experience with Good Clinical Practice (GCP) in the pharmaceutical/clinical research industry.
  • 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, 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Maya Smith at (+1) 267-405-6995 or upload your resume on our website -

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.