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Quality Specialist

Quality Specialist

BelcanDurham, NC, US
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Job Description

Job Title : Validation Quality Specialist

Pay Rate : $35 / hr

Duration : 3 Months

Location : Durham, NC

Area Code : 919, 984

ZIP Code : 27709

Start Date : Right Away

Keywords : #QualitySpecialist #Biomedical

Benefits :

  • Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision
  • 401k
  • On the job training / cross-training
  • Life Insurance, disability insurance
  • Voluntary life insurance for family members available.
  • Accident and critical illness insurance optional.
  • Scheduled performance reviews
  • Referral program

Responsibilities :

  • Ensures current Good Manufacturing Practices (cGMP) and Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance / control documentation.
  • Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation.
  • Assures compliance with SOPs upon implementation.
  • Investigates and proposes additional corrective actions as required.
  • Communicates with Field Quality / Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
  • Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry
  • Write test cases to validate critical control points, user requirements, and functional designs.
  • Execute test cases as needed.
  • Interacts with Donor Center and Field Quality / Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
  • Assists in analyzing validation data to ensure acceptance criteria are met.
  • Assists in writing validation summaries.
  • Ensure milestones and timelines are met on assigned projects.
  • Prepares validation reports for distribution.
  • Evaluates adequacy of corrective actions.
  • Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process :
  • Prepares validation equipment for use at the Donor Center and for evaluation upon return.
  • Assists in identifying and determining actions to add, remove, and / or revalidate processes, systems, and equipment, including evaluation of new / updated methodologies / applications / equipment and resolution of issues or problems with performance, transfer, or service.
  • Tracks and monitors process / system failures / events.
  • Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes.
  • Tracks and monitors equipment calibration due dates and calibration failures / events.
  • Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes.
  • Monitors and trends customer complaints and nonconformance related to equipment failures.

    • Requirements :

  • Bachelor's degree
  • Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
  • Excellent quantitative and analytical skills.
  • Excellent oral and written communication skills.
  • Strong critical thinking and problem solving skills.
  • Ability to identify errors and provide corrective action.
  • Ability to work with others in a team environment.
  • Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.
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