QC Specialist III

Location
27713, Durham
Posted
Jan 14, 2019
Required Education
Bachelors Degree
Position Type
Full time

Under the supervision of the QC Microbiology Supervisor, the candidate is responsible for coordination and execution of activities for quality control programs including the following responsibilities:

Tasks/Responsibilities:

QC Systems

  • Assist in the establishment and ongoing management of the QC Microbiology program.
  • Perform technical writing of procedures, protocols and reports such as action excursions and quality events.
  • Experience with FDA, USP and ISO regulations.
  • Coordinate, assemble, and route documentation to support QC document review and approval as required by Quality Systems Management.
  • Prepare and provide timely and accurate reports and assessments of assigned project (s) and quality metrics to the QC Management.
  • Participate in problem solving exercises to identify the potential root causes.
  • Perform Environmental Monitoring duties to ensure that the GMP processing area is in compliance with regulatory guidelines.
  • Assist with performing microbiological testing of raw materials, In-process and utilities samples.
  • Responsible for maintaining laboratory equipment in accordance with QC procedures,

Competencies:

  • Holds specific technical expertise and assumes a role of support to Supervisor.
  • Able to solve problems independently but will seek out advice from others to assure proper outcome.
  • Excellent knowledge of aseptic techniques.
  • Be able to train new employees and mentor junior employees.
  • Coordination of process or project management teams without direct supervision of staff.
  • Must be able to clearly and concisely document results and communicate them clearly to a variety of teams. Including data review in a timely manner.
  • Must be able to work with multidisciplinary team and represent the group.
  • Completes projects on time by managing personal work schedule as well as cooperate and

    coordinates with members of a team to obtain and/or deliver the necessary data on time.

  • Must evaluate and identify more efficient work processes.  Such as contribute to the

    development of new practices by identifying better approaches to some regular problems.

  • Experience with enterprise applications (example: LIMS, Trackwise, Documentation, SAP) preferred.
  • The employee is required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl
  • The employee must lift and or move up to 20 pounds occasionally.

Education/experience

  • Associate degree in science with a minimum of 6 years of experience.
  • Bachelor’s degree in sciences or engineering with a minimum of 5 years of biopharmaceutical experience.