Quality Assurance Associate
Company: BPL Plasma, Inc.
Location: Commerce City
Posted on: January 13, 2022
- 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
- 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
- Minimum of one-year experience in a quality role, preferably in
a regulated industry.
- Knowledge of FDA and EU regulations and standards
- Strong written and verbal communication skills.
Keywords: BPL Plasma, Inc., Commerce City , Quality Assurance Associate, Other , Commerce City, Colorado
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