What are the responsibilities and job description for the Quality Assurance Manager (Contract) position at TKL Research, Inc.?
We are seeking an experienced Quality Assurance Manager for our growing organization!
In this role, you will be responsible for the review of clinical study documentation. You will handle external and FDA audits, and review SOPs and all other regulatory documents that govern the conduct of the clinical trial. These activities require knowledge of GCPs, ICH, and the applicable parts of the Code of Federal Regulations. You will also be responsible for the oversight and execution of the operational aspects of the Quality Assurance activities.
Minimum Bachelor's degree or equivalent academic credential; health sciences field preferred. Minimum of 6 years of working experience within the clinical, regulatory or quality (pharmaceutical / biotech / CRO) field. Must have detailed knowledge of FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Excellent organizational skills with the ability to be logical and systematic. Excellent written and verbal communication skills. Excellent interpersonal skills. Ability to function independently with minimal supervision. Working knowledge of Microsoft Office Suite. This is a part-time 1099 contract role. Contractor can be home-based, with the occasional need to be onsite in Fair Lawn, NJ.