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

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.

• 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, 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.

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.

• 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…