Quality Control (QC) Technician

Our team is growing, and we currently have an immediate opening for a Quality Control (QC) Technician

Title

Quality Control (QC) Technician

Location

Onsite-Cleveland Office

Reports To

Director of Quality Assurance

Job Overview

Perform analytical testing and visual inspection of in vitro diagnostic medical device finished products, materials, and components in a cGMP laboratory environment. Requires excellent record keeping, attention to detail, time management, and communication. Responsible to communicate 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.

Essential Duties & 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

Qualifications

• 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.

Working Relationships

• Interacts frequently with coworkers and management in Quality Assurance, Manufacturing, and Research and Development (R&D).
• Collaboration is expected to resolve testing and instrumentation issues.
• Interacts with third party instrument service providers.
• Does not have direct reports.

Work Environment / Physical Requirements:

• Ability to operate a computer and software driven lab equipment throughout the day.

• Primary activities are performed in the laboratory. Some activities are performed at a desk and include use of standard office equipment (computer, phone, photocopier, filing cabinets, etc.).

• May include periods of walking, standing, sitting, and light lifting.

• Offices are accessible by elevator but should be able to climb stairs if needed.

• Requires personal protective equipment (PPE) when working in the laboratory.

• Position is on site and does not require employee travel.

• Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples).

• General office and HVAC noise.

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 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

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Compensation details: 60000-80000 Hourly Wage

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