Position: Quality Engineering Associate

This position will work in collaboration with the Quality Engineering team to support operations and continuous improvement efforts for the San Diego Capricor GMP Facility. This position will ensure compliance with Capricor procedures and all applicable regulatory guidelines.

Responsibilities:

• Work collaboratively with other site functions such as manufacturing, Facilities, Safety, and the quality organization.
• Collaborate with the Quality Engineering team to identify process improvements and recommend changes.
• Assist in the review of Calibrations, Preventive Maintenance, and service reports for Equipment’s and Facilities.
• Provide Quality support of the change control technical assessment/evaluation process.
• Prepare reports and documents for review related to Equipment/Facilities and maintenance activities.
• Ensure alignment of equipment/facilities and IT systems qualification with Capricor’s procedures.
• Support regulatory inspections and audits.
• Conduct risk assessments using appropriate tools such as Failure Mode Effects Analysis (FMEA) , Risk Matrix, Decision Tree, etc.
• Support vendor qualification and compliance audits. technical/investigation reports as appropriate
• Track, review and report metric information for use in continuous improvement of areas of responsibility.
• Support continuous improvement initiatives and projects within the site’s quality organization
• Other required duties as may be assigned

Requirements:

• Bachelor’s Degree and 2 years’ experience in pharmaceutical or FDA environment
• Minimum of 2 years of Quality Engineering or validation experience in a GMP environment (Drug Substance or Drug Product)
• Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10)
• Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred
• Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
• Knowledge of audit principles, GMPs and quality assurance
• Proficient in MS Word, Excel, Power Point and other applications
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical personnel

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork