Quality Specialist I or II
KCAS is seeking a Quality Assurance Specialist in our Quality Assurance department. He/she will perform activities of some variety and complexity to assure KCAS management of quality and compliance with applicable regulatory requirements as well as perform document control/ processing functions.
CRITICAL FUNCTIONS:
- Perform quality review of LC/MS/MS and ELISA bioanalytical data, supporting documentation and reports for compliance to SOPs, protocols, methods, FDA Guidance and GLP/GCP regulations and for high complexity CLIA testing for compliance to CLIA regulations.
- Maintain document control utilizing Word and PDF documents on company servers.
- Assist in creation and review of training materials and provide training to company employees.
- Prepare audit reports and communicate them to principal investigator and management in a timely manner. Follow-up with staff to resolve issues and assure compliance.
- Review instrument calibration and maintenance records as well as software validation and instrument qualification records for 21 CFR Part 11 compliance.
- Review deviation and investigation reports to confirm data are accurately reported and comply with SOPs.
- Participate in government and sponsor audits of facilities and systems.
REQUIREMENTS:
- Bachelor of Science or Arts in Chemistry/ Biology or related field or equivalent experience.
- Experience in bioanalytical or GLP lab, Quality Assurance or CLIA is a plus.
- Good oral and written communication and math skills skills.
- Strong computer skills, including Microsoft Office.
- Demonstrated ability to exercise independent judgment with little supervision and work as part of a multi-disciplinary team in a fast paced environment.
- Knowledge of GLP, GCP and/or CLIA regulations.
- Knowledge of FDA Bioanalytical method validation guidance is a plus.
- Understanding of immunogenicity will be helpful.