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QC Analyst I, Sample Management

Raleigh Metro Area, NC

Post Date: 03/28/2018 Job ID: JN -032018-21224 Job Type: Scientific
Description:
Primary responsibilities for this position include performing tasks associated with sample management and reviewing laboratory data. The analyst will be responsible for ensuring that the samples are collected, processed, distributed and reviewed according to quality requirements and results reported are valid, accurate and documented per applicable regulatory and corporate requirements.
Major Accountabilities
  • Performs associated tasks without errors per applicable SOPs and protocols.
  • Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
  • Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
  • Participates in cross-training to support staff availability within QC department
  • Performs shift-work as necessary to support manufacturing operations. Assist in distribution of all samples destined for various QC labs, including third party shipments, on 24/7 basis
  • Perform sample manipulations in a biosafety cabinet
  • Operate the QC Parts washer and autoclave
  • Support for timely and effective investigation of area deviation records
  • Support inventory control of all retain, reference and reserve samples
  • Responsible for ordering and inventory control for glassware and sterile supply to the various QC labs

Skills:
  • 0+ years of directly related laboratory experience OR equivalent.
  • Knowledge of laboratory practices and instruments required.
  • Knowledge of GMPs, safety regulations and data integrity preferred.
  • Experience with Sample Management procedures such as aliquoting, shipping and distributing of samples, as well as operating labware preparation equipment.
  • Knowledge of Labware LIMS functionalities..
  • Bachelor s degree in Scientific discipline or associate s degree and 3+ years of industry experience or equivalent.

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