QA-QC Specialist

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QA-QC Specialist

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    QA/QC Specialist
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  • Assignment Type:

    Direct Hire
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Under limited supervision and with a solid understanding of science and technology, monitors Quality Control activities and develops and manages quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s North American operations.  This position is responsible for ensuring proper QC of finished product and raw materials including stability and other experimental studies as necessary. Conducts investigations and audits, prepares reports, and follow-up on CAPAs to ensure implementation and effectiveness. Supports the Quality Director with maintaining the Quality Management System and general administration of documentation for the QMS. 


  • Support the organization in monitoring the compliance of laboratory testing, manufacturing, and clinical research, and ensuring continued effectiveness of the QMS according to CLIA, CAP, HIPAA, GLP, GMP, and QSR requirements.
  • Represent the Quality unit on cross-functional process improvement project teams.
  • Prepare, maintain, analyze, and present data related to the quality or analytical systems as necessary.
  • Plans and organizes all of the QC activities performed by the quality department and advice/support operations with laboratory equipment and QC processes.
  • Ensures maintenance of Specimen Inventory Databases and reference materials, including cell cultures and stock validation
  • Supports new method and instrument QC development and Validation of procedures, equipment and software as needed including authoring SOPs/Work instructions etc.
  • Audits/reviews documentation to ensure all equipment is calibrated, maintained and serviced as required
  • Assists with the control of Quality Management system records
  • Lead and/or support internal audits, client audits, supplier audits, and regulatory audits including, but not limited to: audit scheduling, audit preparation, audit execution, audit response/resolution, and audit follow-up.
  • Assist in integration efforts and ensure a consistent approach across all company sites wherever possible.
  • Participate in the general Quality Department oversight activities and other duties as assigned.
  • Communicate effectively with internal personnel, as well as external customers and suppliers as needed.
  • Collaborate effectively and positively within department and all other company departments.
  • Represent department and the organization favorably and in accordance with established Company standards.
  • Follow all company safety policies & other safety precautions within the work area.
  • Perform miscellaneous duties as necessary and requested by the Quality Director or other management


  • PhD with 0-2 years of experience or Bachelor’s degree with 5-7 years of experience in a scientific discipline
  • 3-6 years of Quality experience in laboratory setting preferred
  • CAP/CLIA or medical device environment a plus
  • Strong knowledge of scientific principles concepts
  • Exercises sound judgement regarding selecting techniques, methods, and acceptance criteria for results
  • Effectively communicates with employees at all levels of the organization and various departments
  • Good working knowledge of MS programs
  • Experienced in working to GLP and Quality Management principles
  • Strong attention to detail and Quality commitment
  • High standards of mathematics and writing ability
  • Conscientious, thrives in high pressure work, and demonstrates strong initiative

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