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Quality Assurance Associate

Company: BPL Plasma, Inc.
Location: Commerce City
Posted on: January 13, 2022

Job Description:

Duties

  • Assists with review of manufacturing activities, determines in records are in compliance with SOP and regulatory requirements, and ensure corrective action as needed.
  • In the absence of Quality Management, may perform final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.
  • Ensures data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.
  • Communicates with management regarding daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.
  • Assists with or performs ongoing self-inspections to ensure employees correctly perform procedures; identifies deficiencies and works closely with training staff to correct any issues noted.
  • Assists management and training staff in communicating SOP and regulatory changes to involved staff and ensure documentation of training is complete.
  • Assists in analyzing tracking and trending data and determine appropriate actions to improve trending.
  • Reviews center logs and records to ensure information is accurate and/or legible as outlined in the Quality System SOP and ensure corrections are made as needed.
  • Reviews incoming soft goods and medical supplies to ensure accurate receipt and suitability for use.
  • Other job-related responsibilities as required.Qualifications
    • Bachelor's degree in life science or related field preferred
    • Minimum of one-year experience in a quality role, preferably in a regulated industry.
    • Knowledge of FDA and EU regulations and standards preferred.
    • Strong written and verbal communication skills.

Keywords: BPL Plasma, Inc., Commerce City , Quality Assurance Associate, Other , Commerce City, Colorado

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