Quality Control Technologist

Position Summary

The Quality Control Technologist will ensure that performance of finished product is in compliance with testing standards per IFU and SOPs, in addition to customer requirements and regulatory agency guidelines. Perform documentation control duties per Quality Assurance compliance requirements and is responsible for all quality control aspects of finished product testing.

Key Responsibilities

• Review and maintain product compliance specifications and documentation control.
• Perform and interpret microbiology testing, including growth promotion, biochemical testing, and AST.
• Gain proficiency on all performance benches.
• Document testing results and determine product disposition.
• Maintain consistency in training within Master Control.
• Establish and maintain SOP criteria for inspection and testing.
• Maintain department equipment and request consumables as needed.
• Exercise and monitor GMP and GDP compliance in the work environment.
• Execute Stability Study testing in accordance with QA requirements.
• Work in conjunction with Customer Service Representatives to achieve on-time product releases for standing orders and special products.
• Support continuous improvement initiatives within the department.
• Work closely with a team in a fast-paced laboratory setting.
• Understand and follow all safety requirements and procedures.
• Assist in maintaining standards in accordance with GMPs, SOPs, and ISO regulations.
• Train newly added team members.
• Participate in achieving department goals.
• Support all company policies.
• Perform other duties as assigned.

Minimum Requirements/Qualifications

• Possess at least a four-year degree in the biological sciences, including coursework in microbiology with a laboratory component, or an equivalent four-year degree.
• Have a minimum of 1-2 years of combined experience in QC/QA, microbiology laboratory work, or an equivalent combination of education and experience.
• Demonstrate familiarity with FDA regulations for medical devices.
• Possess the ability to manage multiple tasks in an organized manner.
• Have intermediate computer skills, preferably including Microsoft Word, Excel, and PowerPoint; SAP experience is a plus.
• Listen to and follow written and verbal instructions.
• Adapt to and learn new procedures while maintaining a scientific and objective approach.
• Be available to work weekend shifts and overtime when needed.
• Be self-motivated, highly responsible, and possess strong teamwork skills.
• Demonstrate excellent verbal and written communication skills in English.
• Must be willing to work overtime when needed to complete tasks.
• Must possess strong critical thinking skills.