Quality Assurance Manager
- Greater NJ area
A leading genomics organization is actively seeking an experienced Quality Assurance Manager to join their growing team. Working with cutting edge pharmaceutical and biotechnology companies as a full service provider for DNA sequencing and gene synthesis. The QA Manager will be responsible for providing leadership to the QA team to make sure regulatory needs are being met. This is a great opportunity if you are looking to take the next step in your career and have interest in shaping team culture while contributing to a company's growth.
Main Responsibilities:
- Directs all QA efforts and activities in order to maintain an effective quality management system
- Collaborate with senior leadership to set up business and quality team objectives
- Make improvements to the QMS, making sure both company and regulatory standards will be met
- Handles all compliance efforts with CAP, CLIA, GMP, GCP, and GLP guidelines
- Manages the review and approval of SOP's and other QA documents
- Conducts internal facility audits as well as external client or third party audits
- Drives continuous improvement and CAPA activities based on different quality findings
Qualifications:
- Bachelors degree in a Life Science field
- 5+ years of related experience, with at least 2 years of managerial experience
- Working knowledge of regulation and compliance qualifications
- Ability to manage multiple projects and meet time lines
- Strong knowledge of QMS
