Quality Control Technician

Job purpose

The Quality Control Technician will be responsible for performing routine and non-routine analytical testing along with data entry and analysis for lot release of reagent and consumable components of invitro diagnostic products.

Duties and responsibilities

• Quality Control Testing
  • Perform laboratory lot release testing and other analytical testing using laboratory equipment such as plate readers and specialized test instruments.
  • Collect and enter data.
  • Perform troubleshooting to investigate discrepancies and solve problems.
• Quality Assurance Reviews
  • Monitor and inspect production lines to ensure that quality and package/label integrity are within specifications.
  • Verify that product codes, labels, cases, cartons are correct.
  • Perform DHR review and lot release. 
•   Complete and maintain documentation associated with quality checks.
•  Effectively communicate technical and analytical data using reports, charts, graphs, etc.as required.
•   Maintain QC test lab facility through routine EQP maintenance, lab cleaning, and replenishment of lab supplies
•   Comply with U.S. FDA regulations, other regulatory requirements, company policies, operating procedures, and processes.
•   Carry out special projects as needed.
•   Participate in quality improvement initiatives.
•   Other QC/QA duties as assigned

Qualifications

Qualifications include:

• Education: 
  • Associate degree or higher in Chemistry, Analytical Chemistry, Biochemistry, Biology, Chemistry or related area of study, or NC BTEC (Biomanufacturing Training and Education Center) relevant certification(s).
• Experience:
  • 2+ years of industry experience in a FDA-regulated analytical test laboratory environment preferred.
• Required Skills, abilities, characteristics: 
  • Ability to carry out assigned tasks in a timely manner.
  • Highly proficient in lab environment: testing, troubleshooting, documentation, set-up, training, problem solving.
  • Willingness to work in a laboratory environment with biological specimens.
  • Experience in wet chemistry techniques especially micro-pipetting, extractions, titrations.
  • Proficient computer skills with the knowledge and ability to collect, document, and interpret analytical data.
  • Experience with Microsoft Word and Excel.
  • Experience working in an FDA regulated in vitro diagnostic facility using state-of-the-art and advanced techniques and procedures desired. GMP (Good Manufacturing Practices) experience desired.
  • Ability to work independently and a motivated self-starter.
  • Good verbal and written communications skills.
  • Flexibility to handle changing priorities and deadlines while maintaining a high quality of work.
  • Familiarity with CLSI guidelines preferred.

Working conditions

• 2nd shift with flexibility for 1st shift and weekend work, when required.

Physical requirements

• This position is very active and requires regular standing, walking, twisting, grasping, reaching, bending, kneeling, sitting, stooping. Manual finger, hand, and arm dexterity, and ability to work around cramped and tight spaces will be needed. Specific vision abilities required by this job include close vision, distance vision, color vision to detect color-changes in testing and labeling, peripheral vision, depth perception, and ability to adjust focus.

Direct reports

None