Quality Control (QC) Technician

Cleveland Diagnostics • Cleveland, OH

3h • Onsite

About The Position

Our team is growing, and we currently have an immediate opening for a Quality Control (QC) Technician. This role involves performing analytical testing and visual inspection of in vitro diagnostic medical device finished products, materials, and components in a cGMP laboratory environment. It requires excellent record keeping, attention to detail, time management, and communication. The technician is responsible for communicating unexpected issues, events, or results to Quality Management. Decisions or errors may cause minor delays or negative impact to process efficiency, timelines, data integrity, or cGMP compliance. Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. The company prides itself in fostering a family-focused, friendly, and flexible organization that places employee’s well-being and happiness as the primary reason for its success. They are interested in individuals who want to build their career with a team of industry professionals while making a lasting impact on the lives of millions of people.

Requirements

• Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering.
• ≥ 2 years of experience in a QC or laboratory role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing.
• Knowledge of and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR.
• Knowledge and experience with current good manufacturing practices (cGMP), good documentation practices (GDocP), and good laboratory practices (GLP).
• Excellent record keeping skills and ability to follow detailed procedures.
• Excellent verbal and written communication skills.
• Computer proficiency with Microsoft Office products.

Responsibilities

• Performs analytical testing of incoming materials and components according to approved test methods and specifications.
• Performs incoming material sampling and visual inspection.
• Executes protocols for stability testing and similar studies.
• Operates laboratory instruments and equipment such as Roche Cobas e411 immunoanalyzer, vortex mixer, bench top lyophilizer, and centrifuge.
• Performs tests including pH, conductivity, density, viscosity, and moisture (bench top lyophilizer).
• Performs instrument troubleshooting to address and resolve unexpected performance or results obtained.
• Documents laboratory activity performed according to good laboratory practices (GLP) and good documentation practices (GDocP).
• Completes laboratory testing related sections of the batch record and associated production records.
• Supports the verification and maintenance of laboratory records.
• Performs routine maintenance and calibration of laboratory instrumentation.
• Monitors laboratory consumables stock for routine testing activities.
• Schedules service calls for instrumentation and guides third party technicians during service.
• Participates in the investigation of out of specification (OOS) test results, including the determination of root cause and implementation of corrective actions.
• Anticipates and communicates issues with laboratory procedures and participates in team discussions to resolve them.
• Participates in third party audits or inspections to demonstrate testing or laboratory related activities.
• Participates in the creation, revision, and implementation of QC procedures, forms, and work instructions to improve current processes.
• Completes and maintains up-to-date employee training for all activities performed.
• Supports assigned quality assurance (QA) related activities during periods of downtime
• All other duties as assigned

Benefits

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees