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QC Specialist (Data Reviewer)

at BioAgilytix

Posted: 9/1/2019
Job Status: Full Time
Job Reference #: 1154743
Categories: Other/General

Job Description

  • QC
  • Durham, NC, USA
  • Full Time

Essential Responsibilities

  • Quality Control (QC) technical, scientific and compliance review of data generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP)
  • Coordinate work prioritization with the QC Manager, Bioanalytical Project Managers and Quality Assurance to ensure that study timelines are met
  • Identify deviations, OOS and OOT associated with Bioanalytical Operations data
  • Issue QC review observations and work closely with the scientific staff to ensure compliance with appropriate regulations
  • Function as a Subject Matter Expert in regard to QC processes
    • May serve as a backup trainer on the QC review process
    • May act as a mentor to junior-level QC data reviewers
  • May review protocols, testing plans, reports and other study-related documentation
  • Assist in collecting metrics data used to monitor the QC processes and may identify and assist with implementing QC process improvements
  • Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance
  • Write and/or review QCT SOPs
  • Other duties as needed


Minimum Acceptable Qualifications


  • Bachelor's degree in biological science or related field with not less than two (2) years' experience working in biotech, pharmaceutical, CRO/CMO or similar organization
  • Knowledge of GxP regulations
  • Experience with large molecule bioanalytical methods such as immunoassays and cell-based assays
  • Experience performing data review in a GxP environment


  • Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
  • Ability to take direction well and multi-task
  • Acute attention to detail and organizational skills
  • Excellent oral and written communication skills
  • Demonstrated proficiency in MS Excel and Word
  • Demonstrated proficiency in LIMS and Quality Management software packages


Working Environment

  • Primarily office
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets


Physical Demands

  • Ability to work in an upright and/or stationary position for up to eight (8) hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
  • Occasional mobility needed
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including office materials and laptop computer with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance


Position Type and Expected Hours of Work

  • This is a full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and evening work required