We envision a Luminex solution in every lab around the world seeking to obtain timely and confident answers. We aim to lead with transformative solutions that uniquely accelerate reliable answers while reducing the overall cost of advancing health.
The QC Associate will be responsible for:
- QC testing of final product consumables and various reagents to support QSR and development activities.
- Working closely with the Investigations Group to carry out nonconformance investigations, as well, as investigations to support CAPAs.
- Preparing and qualifying QC test samples, as necessary.
- Supporting equipment calibrations as required.
Key Responsibilities & Duties
- Perform final product QC functional testing to support QSR and development
- Work closely with the Investigations Group to conduct CAPA and nonconformance investigations
- Perform QC testing of reagents, as necessary
- Prepare and qualify various QC test samples required for various QC functional testing.Test samples include but are not limited to CCL DNA, DNA from whole blood, and bacterial and viral targets
- Ensure that all generated lab documentation is QMS compliant
- Perform raw materials testing as required
- Perform environmental testing as required
- Support required equipment calibrations as required
- Other duties as assigned.
Education and Experience
- Science degree, or equivalent, in a technical field or 3-5 years of experience in IVD, Medical Device or Pharmaceutical Industry.
- Experience working in a c GMP Quality Control department in a FDA regulatory laboratory environment.
- Relevant combinations of education, experience, certifications, and merit may be considered upon the review of Senior Manager Quality Control
Training, Skills, and Certifications/Licenses
- Ability to analyze, understand and effectively communicate technical material
- Ability to organize and judge priorities in a dynamic environment
- Must work onsite at Luminex office
- Travel may be required at least 10% of the time
- Work is normally performed in a manufacturing work environment
- Frequent use of personal computer and office equipment
- Frequent standing, walking, sitting, listening, and talking
- Frequent work under deadlines supporting production, as a team member, and in direct contact with others
- Possible exposure to Chemicals, Lasers, Excessive Noise, etc.
- Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting at least 10 lbs.Additional physical requirements are listed below:
- Pounds lifted (20 to 50lbs)
- Vision (Color) on the job is required occasionally
Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.