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Quality Lab Technician

Location: 

Dover, DE, US

Req ID:  659
Job Type: 

 

Position Summary

Conduct testing of raw materials, in process and finish good samples in accordance to local, corporate procedures and cGMP guidelines.  Work on routine and non-routine laboratory projects as directed by Quality Laboratory Management. 

Universal Accountabilities

  • Perform testing using a variety of analytical techniques, such as GC, IR, Instron-tensiometer, chemical extractions, assays, absorbency, etc. Other physical tests such as string performance, ejection force, compression, specific gravity, viscosity, moisture, particle size and loss on drying.
  • Perform all laboratory tasks and laboratory activities such as, testing, documentation, in accordance with cGMP and 21CFR 820 requirements.
  • Collaborate with internal and cross-functional colleagues to assure testing and releases are completed on time
  • Manage material flow in conjunction with Planning and Scheduling.
  • Follow SOPs, test methods and approved written procedures in the laboratory.
  • Maintain 5S standards in the lab.
  • Must display accuracy and attention to detail while completing testing and documenting results with minimal errors.
  • Work on non-routine projects as directed by the laboratory supervisor
  • Must be able to cross train on different laboratories and activities across the quality control organization.
  • Support laboratory supervisor in OOS investigations. Compile data, and participate in the different steps of the investigation process.

Specific Accountabilities

  • Perform job duties in a compliant and safe manner
  • Adhere to testing and projects deadlines as assigned by quality laboratory management
  • Adhere to 5 S standards in the laboratory.
  • Escalate non-conformances and Out of Specification results in a timely manner and in accordance to local and corporate procedures.
  • Keep up with laboratory productivity standards.
  • Adhere to designated work schedule.

 

Required Skills and Experience

  • BA or BS in a technical discipline such as Biology, Chemistry, Chemical Engineering, Microbiology or related field or equivalent experience.
  • Must be able to work with minimum supervision.
  • Effective verbal / written communication, interpersonal, and team-building skills.
  • Excellent organizational, problem-solving, prioritizing and follow-up skills.
  • Ability to handle multiple tasks / projects simultaneously.
  • Good computer skills. 
  • Must be able to learn and work with computer software such as SAP, LIMS, chromatographic applications and other laboratory software.
  • Must be willing to occasionally work OT as needed.
  • 0 to 1+ year of experience working in a cGMP laboratory

 

Preferred Skills and Experience

  • Experience working in a FDA regulated laboratory.
  • Working knowledge of SAP and LIMS.
  • Working knowledge of FDA 21 CFR part 820, 210 and 211 requirements.
  • Working knowledge of Canadian Medical Device Regulations SOR/98-282
  • Working knowledge of ISO 13485 and 14971 requirements

 

Working Relationships

  • Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
  • External contacts:  contract laboratories, laboratory supply vendors

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Nearest Major Market: Delaware
Nearest Secondary Market: Dover