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Quality Control Analyst

Raleigh Metro Area, NC

Post Date: 02/26/2018 Job ID: JN -022018-21031 Job Type: Scientific

*This Analyst II role is supporting Microbiology. The schedule will include Saturday coverage. The worker can choose to work Tues-Sat, 8am - 4:30pm, or Wed-Sat, 7am - 5:30pm.

Job Purpose
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.
Major Accountabilities
  • Performs testing and 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
  • Performs shift-work as necessary to support manufacturing Participates and performs in cross-training to support staff availability within QC department
  • Develops and maintains SOPs
  • Develops expertise in assigned assays/techniques
  • Authors deviation and invalid assay assessments
  • May be required to perform shift work as required to support operations

  • 3+ years of laboratory experience OR equivalent
  • Intermediate knowledge of GMPs, safety regulations and data integrity
  • Intermediate knowledge of analytical methods and related instrumentation.
  • LIMS experience preferred
  • Technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), sterility testing, growth promotion testing of microbiological media, identification of microbiological isolates, antimicrobial effectiveness testing (AET), water and Clean Steam collection, gas sampling, environmental monitoring (EM) and EM trending

Bachelor s degree in Scientific discipline and 3+ years experience or associate s and 5+ years of industry experience or equivalent

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