Quality Control Technologist

Work Schedule

Environmental Conditions

Job Description

Company Information

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) leads in serving science focusing on health cleanliness and safety.

Job Description

Job Title: Quality Control Technologist

Reports To: Quality Control Supervisor

Group/Division: MBD

Career Band: Band IV

Job Track: Quality Assurance

Position Location: Lenexa Kansas

Day/Shift (if applicable): M-F

FLSA Status (Exempt/Non-Exempt): Exempt

Position Summary:

Accountable for handling all quality assurance elements in testing the final product. Ensure that performance of finished product is in compliance with testing standards per IFU and SOPs in addition to customer requirements and regulatory agencies guidelines. Documentation control duties per Quality assurance compliance requirements.

Key Responsibilities:

• Review and maintain product compliance specifications documentation control.
• Perform and interpret microbiology testing including growth promotion biochemical AST.
• Gain proficiency on all performance benches.
• Document testing results and resolve disposition.
• Maintain consistency in training in Master Control.
• Establish and maintain SOP criteria for inspection/testing.
• Maintain department equipment and request consumables as needed.
• Exercise and supervise GMP compliance in work environment.
• Work closely with Quality Assurance department as a quality team.
• Conduct Stability Study testing following QA guidelines.
• Collaborate with Customer Service Representatives to achieve timely product releases for standing orders and special products.
• Engage in the continuous improvement program within the department.
• Partner with a team within a multifaceted laboratory setting.
• Understand and exercise all safety requirements and procedures.
• Help uphold standards following GMPs/SOPs and ISO regulations.
• Participate in achieving department goals.
• Support all company policies.
• Perform other duties as assigned.

Minimum Requirements/Qualifications:

• Hold a 4-year biological sciences degree with microbiology coursework plus lab or a 4-year degree with 5 years of microbiology lab experience.
• At least 1-2 years experience in QC/QA or microbiology lab work or equivalent education/experience.
• Familiarity with FDA regulations for medical devices.
• Ability to handle many tasks and in an organized fashion.
• Communicate optimally with a variety of departments in regard to quality testing parameters.
• Intermediate digital literacy preferably with experience in Microsoft Word Excel and PowerPoint. Experience working in SAP is a plus.
• Listen to and follow written and verbal instructions.
• Adapt and learn new procedures while maintaining a scientific and objective approach.
• Available to work weekend shifts when needed.
• Self-motivated highly responsible and possess a good team spirit.
• Excellent verbal and written skills in English.