Quality System Engineer (QA, Biomedical industry, East, Perm) - Generous Compensation

Location: East

Working Hours: Mon – Fri: Office hours

Salary: Up to $3,300 per month + PB 

Job Description:

• Assure company’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions.  Communicate all identified compliance and quality risks to supervisor.
• Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations. 
• Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections.  May participate in the support of client site visits.
• Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. 
• Participate in the execution of site-wide applicable regulations or standards (ISO/GLP/GMP) training sessions, as developed and approved by senior Quality Systems team members.
• Participate in the preparation of support during regulatory inspections, as required.
• Participate in the performance of internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Perform facility and equipment records and logbook reviews.

Requirements:

• Bachelor’s degree (B.S. / BA.A.) or equivalent, preferably in a life science 
• Minimum of 2 years in a Quality Assurance role. 
• May require occasional domestic and/or international travel (up to 10%).