We are currently hiring for a QA Associate in our state-of-the-art laboratory. This is a 1st shift position, contract to hire with a cutting edge biotech company in Boston.
The purpose of this job is to support the Quality Management System and assure that all products are in compliance with current Good Manufacturing Practices (FDA), ISO 13485, European and Health Canada regulatory requirements.
ESSENTIAL JOB FUNCTIONS*
- Perform review of batch records, QC documents, and all other quality records to ensure compliance in a timely manner to meet company objectives. Perform Final Product release as assigned.
- Initiate, review, and revise company standard operating procedures, manufacturing batch records, QC records, cleaning records, and other corporate documentation as assigned.
- Maintain the company's stability program for products including writing protocols, reports, scheduling testing, and data trending.
- Contribute to the Company's process deviation, NCR, CAPA, Complaint, and Internal Auditing systems, by preparing documentation and tracking due dates. Verify implementation of corrective actions to ensure continuous improvement.
- Maintain data bases for trending quality data.
- Assist with the maintenance of Design Control, Risk Management and Process Validation processes and documentation for the development of new medical devices.
- Ensure compliance of the company’s equipment program by maintaining the equipment list, scheduling routine equipment calibration, writing qualification protocols and SOPs, and reviewing the resulting quality records.
- Assist in the maintenance and implementation of the company's training program for all employees by distributing training documents and tracking training.
- Contribute to the Company's Vendor Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance.
- Maintain the quality system in a state of inspection readiness by ensuring ongoing compliance with FDA, ISO 13485, European and Health Canada requirements.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
- Thorough knowledge of cGMP, GLP, and GCP principles is required. Knowledge of ISO 13485, European, and Health Canada regulations. Experience with Quality System management and regulations
- Bachelor's degree in biology or a related life science
- Familiar with laboratory standard operating procedures, standard test procedures, analytical instruments trouble-shooting, calibration and preventive maintenance of analytical instruments, qualification of analytical instrumentation
- One to five years experience in a cGMP quality, regulatory, and/or medical device manufacturing environment
- Ability to interact positively and effectively with other departments within the organization (eg., R & D, Manufacturing, QC)
- Ability to adapt quickly to changing priorities and projects
- Ability to work independently on assigned projects with minimal supervision
- Ability to remain calm and poised under pressure as when confronted with audits from outside Regulatory agencies (FDA, ISO)