Quality Assurance Manager

Description:

Looking for someone who will be reviewing reports and maintain quality systems for in vitro testing for toxicology and biocompatibility studies (e.g., ISO 10993). Examples include cell culture studies to evaluate cytotoxicity, irritation, genotoxicity, and other biological effects of products and materials. These studies are used by clients during product R&D as well as regulatory body registration. As industry testing shifts away from in vivo methods and to in vitro models, we expect this new endeavor to be an exciting and successful addition to other services.

Job Description

We have an opening for an In Vitro Quality Assurance Manager. The skills and responsibilities include:

• Maintain quality system in laboratory setting in accordance with GLP, GMP and ISO standards

• Work closely with laboratory operations staff and review standard operating procedures, protocols, methods, and reports

• Perform intra-study quality checks to determine conformity to SOPs

• Review final reports to determine conformity to SOPs

• Assist in the validation and certification of laboratory instrumentation

• Help with internal and external audits of the quality management system as well as client visits

• Exhibit proficiency in Microsoft Office (Including Excel, Word, Outlook, etc.)

• Work comfortably in a fast-paced environment with firm deadlines

• Collaborate effectively in a team environment

EDUCATION

Minimum of B.S. in Biological Sciences, Microbiology, Biomedical Engineering, Chemistry, Data Science, or other scientific discipline

EXPERIENCE

• Experience with GLP and GMP is required

• 3-5 year of laboratory or industry experience in a GLP environment along with experience with documentation/quality assurance. Preferred experience with ISO and 21 CFR.