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