QA Associate　※CMIC, Inc.

POSITION PURPOSE:

The Quality Assurance Associate is responsible for assisting with implementation and maintenance of a quality system to support bioanalytical lab operations. Assist with the development and execution of regulatory training for all CMIC, Inc. employees and for training on quality assurance policies, programs, and initiatives. Ensure documents are reviewed and processes are carried out in accordance with company quality policies and procedures are compliant with GLP requirements. Responsible for writing and reviewing quality documentation. Conduct in lab audits and review of study plan raw data and report supporting regulatory studies. Assist with process and facility inspections.

RESPONSIBILITIES:

• Serve as a source of quality assurance and GLP guidance to functional departments.
• Assist with QAU administration.
• Participate in the maintenance of quality document management system.
• Assist QA unit with awareness of compliance issues.
• Review site procedures and ensure consistency of content of standards with GLP requirements.
• Conduct and report inspections of study specific procedures and processes.
• Reviews study plans, SOPs, raw data, methods and study reports; ensures that no deviations from approved requirements were made without proper authorization/documentation and were performed in accordance with the GLP regulations (as applicable).
• Assist with conduct and reporting of Process and Facility audits.
• Assist with training in GLP for Bioanalytical personnel.
• Participate in QA-Bioanalytical meetings.
• Additional duties as required and assigned.

Qualifications

• 2+ years working in a GLP environment;
• 1+ years in a quality assurance or related role
• Knowledge on Bioanalysis
• B.S. in related field

Experience and Skills

• Good understanding of FDA GLP; Sound understanding of quality systems in CRO, life science, pharmaceutical industry.
• Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems.
• Ability to handle confidential information with organizational skills for filing and file maintenance.
• Ability to prioritize and complete work in a timely fashion and demonstrate attention to detail.
• Good team player and experience of dealing with complex tasks.
• Demonstrated effective oral and written communication skills and excellent interpersonal skills; ability to deal with people at all levels.
• Time-management skills are required, as well as the ability to handle multiple projects.

APPLICATION:

Application method
Interested parties please apply via HR@cmicgroup.com

Responsible Person Contact details
Name: Denise Washick
Email: Denise-Washick@cmicgroup.com