The position of Quality Assurance Technician is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working independently in a clean room environment and meeting the demands of production timelines and commitments.
This position is responsible for:
PRIMARY RESPONSIBILITIES
Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements. Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, product release, etc. Authorize release of approved material, intermediates and finished product. Prevent release of suspect or known nonconforming products and materials. Perform microbiological testing of environment and products as necessary. Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices. Follow detailed process steps without deviation. Organize reports, files, and results in a professional proficient manner. Conduct training to Quality Systems processes as defined within the internal learning management system. Be flexible and work within a small team without strictly defined roles to assure complete functional coverage.
EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS
High school degree. Fluent in English (read, write and speak). Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment. Previous experience handling chemicals and using basic chemical laboratory equipment preferred but not required. Previous experience working in a medical device, pharmaceutical, or other regulated industry preferred but not required. Personable, energetic, responsive and confident. Strong organization and time management skills. Self-starter with the ability to learn and work as part of a team. Strong verbal, written, analytical, persuasive skills and ability to interact effectively with all levels. Strong interpersonal skills, energetic, proactive, flexible with high integrity and ethics in all dealings. Basic office computer skills (email, word processing, and spreadsheet software).
TRAINING REQUIREMENTS
Undergo all formal Training Events as may be directed from time-to-time. Observe and comply with all Corporate Policies. Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements. Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.
