Clinical Quality Assurance Associate VaxInnate
THIS JOB HAS EXPIRED The Clinical Quality Assurance (CQA) Associate is responsible for the development, enhancement and/or maintenance of CQA systems, under the direction of the Associate Director, Quality Systems. Develops audit plans to ensure all clinical trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements. Conducts CQA audits of clinical sites, clinical quality systems, clinical vendors and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements. Ensures work is carried out according to GCP standards as defined in the ICH Guidelines, corporate policies and procedures, and all regulatory requirements.
Primary Job Duties Include:
Development of CQA plans and implementation of the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirements
Conducting internal and external clinical quality systems and clinical vendor audits and ensures that all audits are followed-up and corrective actions are completed, implemented, and verified
Assists with CQA quality systems and supports department infrastructure development; assist with creation/revision of appropriate CQA SOPs
Assists with GCP training activities
Facilitates investigations of GCP-related matters (e.g., product complaints)
Review of regulatory submission documents, including the Clinical Study Report and other essential documents (Protocol, Informed Consent Form, and Trial Master Files)
Assists in the development of metric reports to CQA management of all issues related to the outcome of the audits
Other duties as assigned.
Minimum BA/BS Degree in biological sciences, chemistry, or related field with a minimum of 5 years (more preferable) of demonstrated practical experience in Clinical QA for the biotech/pharmaceutical industry;
Excellent working knowledge and understanding of GCP-related requirements, proficiency of regulatory and ICH guidelines. Broad experience in the pharmaceutical industry with a strong clinical development background
Strong attention to detail and excellent verbal and written communication skills.
Excellent verbal and written communication and interpersonal skills
Up to 10% travel may be required
||Three Cedar Brook Drive |
Cranbury, NJ 08512
THIS JOB HAS EXPIRED