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Quality Control Specialist II

2 months ago

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The Quality Control (QC) Specialist II – Compliance will provide support for a wide variety of QC Compliance requirements for the laboratory activities facilitating testing of cell-based therapeutics destined for human clinical trials. The QC Specialist II will be one of the key contributors in driving all aspects of the QC laboratory compliance through appropriate quality systems. The candidate will report to the Senior Specialist, QC Compliance and work closely with the QC Testing team and Analytical Sciences team to provide support in quality aspects. The QC Specialist II will be instrumental in ensuring compliance within the laboratory through issues, change controls, deviations, lab investigations, CAPAs, change actions and audit support. The candidate will also support management of documentation. Duties include control of the GMP documentation and data generated, aiding in the quality and compliance of the laboratory operations and data integrity for testing in the QC lab to meet applicable U.S., Canadian and global standards.

  • Work closely with Quality Assurance (QA) and Quality Control (QC) assay SMEs or process owners to support management of QC-related quality records in the electronic Quality Management System (eQMS), i.e., issues, change controls, deviations, lab investigations, CAPAs, change actions and audit activities relevant to testing, equipment, and processes etc.
  • Handle routine quality records independently and have the capability to advance the ones with moderate complexity under minimal supervision.
  • Be involved in drafting and pushing quality records for on time closure and/or guiding the quality record owners (i.e., QC assay SMEs) to achieve.
  • Track and update the progress of all quality records pertaining to QC at regular basis.
  • Support authoring and review of SOPs related to QC activities and provide QC input for cross-functional SOPs relating to general GMP compliance.
  • Support management of QC documentation workflow, including GDP compliance of laboratory records.
  • Other duties as required.
Minimum Requirements:
  • Minimum of a Bachelor’s degree in Biological Sciences or related field with a minimum of 3+ years of relevant experience in the industry is required OR a Master’s degree with 1+ years relevant experience is required.
  • Experience in Quality Control within the Biotechnology setting is a must, strong preference particularly for experience in Cell therapies in a cGMP-compliant environment.
  • Highly familiar with laboratory operations, standard procedures and instrumentation, for testing of biologicals is preferred.
  • Compliance mindset for the execution of elements within the quality system, including Change control, Deviation management, and CAPA implementation.
  • Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
  • Excellent written and oral communication skills, with strong organizational skills, keen attention to detail and proven ability to be highly productive and successful in a high pace work environment.
Work Environment:
  • In this position you will work in a controlled laboratory environment.
  • You may be periodically required to move heavy equipment around up to 50 lbs.
  • Working in the laboratory requires mandatory use of personal protective equipment.
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