Quality Control; QC Technician

Title

Quality Control (QC) Technician

Onsite-Cleveland Office

Director of Quality Assurance

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.

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

• 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, ISO
  13485, 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.

• 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.

• Bachelor’s degree in a scientific discipline such as chemistry, biology, or engineering.
• ≥ 4 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing.
• Working knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO
  13485, or EU IVDR.
• Working knowledge and experience with current good manufacturing practices (cGMP) and good documentation practices (GDocP).
• Excellent verbal and written communication skills.
• Excellent computer proficiency with Microsoft Office products.
• General office and HVAC noise.

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage.
• No cost for employee coverage for Group Term Life, Short & Long Term Disability.
• 4% retirement contribution Employer match.
• Paid Family Leave 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.

Pay Range: $60,000 - $80,000 per hour

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. 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.