Description:

This individual is primarily responsible for performing Quality Control testing products at various stages of Production. This includes both routine (SOP) and special assignments, as well as documentation of findings/results for attachment to Device History Records. Additionally, this individual will lend support as necessary to the daily QC Chemistry core functions – Stability Studies, Raw Material Testing, Proficiency Testing, and Customer Complaints.

ESSENTIAL FUNCTIONS:

• Performs and documents QC Testing of WIP Production Lots and special evaluation assignments.

• Support daily QC Chemistry core functions as needed.

• Performs and documents 1st article functional Sofia Final Kit QC Testing.

• Support new Sofia product development/improvement projects.

• General housekeeping and laboratory organization.

• Carries out duties in compliance with established business policies.

• Works and communicates effectively and professionally with others.

• Capable of working and communicating with other departments regarding testing activities.

• Operate laboratory equipment safely, as trained and directed, in accordance with established practices.

• Train new Quality Control Technicians.

Additional Skills & Qualifications:

EDUCATION, SKILLS & EXPERIENCE (indicate if required or preferred): Education/Experience • Bachelor’s degree in Chemistry, Biology, Life Science or similar discipline or equivalent experience preferred. • 0-2 years’ in Quality Control or manufacturing laboratory environment. • Experience in a medical device, high-volume manufacturing environment strongly desired. Knowledge/Skills • Ability to read, interpret and follow detailed procedures, instructions and drawings • Solid understanding of QSRs/ISO • General chemistry and laboratory skills, GLP/GMP experience • Demonstrated team-oriented interaction skills/professional behavior • Strong written and verbal communication skills • Proficient word processing, data entry, and spreadsheet navigation skills • Must know basic quality terms, definitions and concepts • Must understand traceability (product, material, and calibration) Individual must have a working, technical background and a common-sense knowledge base to be able to make daily decisions regarding Production, QC, and chemistry/biology. Work within defined regulations and timelines. Possess the ability to discern product and process integrity to defined standards and methods, with the initiative to take appropriate action. Problem solving developed to the point of identifying processes and standards in need of improvement and suggesting/initiating appropriate action. Performs daily activities with minimum supervision and demonstrates consistent ability to problem solve/resolve issues associated with various aspects/departmental functions with minimal assistance. Operates predominately independently for routine decision-making and seeks involvement of appropriate individuals when warranted. Have a demonstrated ability to prioritize workload. Individual must be able to apply problem solving/decision making skill to personnel interactions and incidents to successfully diffuse potential problems.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.