Description

Position Summary:

Quality Assurance Technician will ensure the quality and reliability of the processes and products by inspecting the production areas and review documentation. Review and release of shipments. Document issues and inform the appropriate people of the situation.

Responsibilities:

• Follow SOPs, test methods and approved written procedures.
• Update SOPs as needed 
• Collaborate with internal and cross functional colleagues to assure testing and releases are completed on time. 
• Perform inspections by using processes and procedures set in place for determining whether incoming and finished products are of a specified quality and report results to management. 
• Investigate and report all non-conformance findings. Investigate a quality event through internal company processes to identify the root cause and possible solutions.
• Ensure proper documentation of processes, product quality and review. 
• Help maintain, file and archive all quality and process related documents.
• Communicating quality issues and concerns immediately with all relevant personnel to achieve timely and effective results.
• Perform line checks on production floor by pulling/testing product samples inspecting pallets for shipment to ensure product quality.

Requirements

Required Skills/Abilities:

• Knowledge of quality system and cGMP processes
• Ability to coach and correct individuals in a polite, collaborative manner
• Ability to prioritize responsibilities and daily workload. 
• Communicate effectively with members of organization and management
• Attention to detail and high level of accuracy & organization
• Ability to work independently with minimal supervision in a fast-paced environment
• Ability to adapt quickly to changing policies and procedures
• Proficient knowledge of computers and Microsoft Office.

Required Education and Experience:

• Associate or technical degree OR equivalent years of experience in Quality-related disciplines.

Preferred Education and Experience:

• BS degree in Chemistry, Biology or related field
• Two or more years of experience in a manufacturing and/or Quality Control area
• Working knowledge of FDA 21 CFR part 210 and 211 requirements.