Quality Control (QC) Technician
Company: Cleveland Diagnostics Inc.
Location: Cleveland
Posted on: May 1, 2025
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Job Description:
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
- - - -Ability to operate a computer and other technology related
lab equipment through course of 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 or
light lifting
- - - - - - - -
- - - -Offices reachable 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
- - - -Other Requirements
-----------------------------------------------
Cleveland Diagnostics, Inc., is developing highly efficacious,
lab-friendly, affordable diagnostics tests using proprietary
technology to improve cancer diagnostics. Its portfolio of
non-invasive diagnostics will be expanding from prostate cancer to
breast cancer and lung cancer. 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:
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.
PIab4f5c1e8e89-37248-37331936
Keywords: Cleveland Diagnostics Inc., East Lake , Quality Control (QC) Technician, Professions , Cleveland, Florida
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