Quality Assurance Coordinator

Classification:
Hourly/Non-Exempt

Reports to:

QA Manager

Ensure Plasma Center compliance with all Company’s Standard Operating Procedure Manual (the “SOPs”),current

Stateand

Federal guidelines,OSHA,CLIA,cGMP,andanyotherinternalCompanyprocedures

• Authorized to STOP PRODUCTION
• Authorized to STOP RELEASE OF SHIPMENTS
• Authorized to institute new and revised procedures and forms when received from or requested by corporate.
• Assist in the ongoing development of the Q.A. program.
• Implement effective manufacturing process and systems controls.
• Perform all tracking and trend analysis requirements and provide the information to the Manager and corporate.
• Conduct monthly audits and discuss with the Quality Manager any compliance issues.
• Review donor records on a daily basis for accuracy (donor selection, acceptability, deferral, adverse reactions, and collection).
• Review plasma storage and distribution records as needed.
• Review of all donor reaction issues and complaints.
• Review of maintenance and cleaning records.
• Reviews issues and perform investigations.
• Review logs on a daily, weekly, monthly basis as required.
• Review/release of samples to laboratory.
• Review plasma packing.
• Ensure all plasma shipments meet specifications and requirements as defined in the SOP and/or the consignee specifications.
• Ensure accurate labeling and documentation of shipments.
• Authorize final shipment release.
• Ensure that CLIA proficiency test surveys, complaint investigations and training have been properly documented.
• Monitor and follow-up on corrective actions and preventative measures (CAPA).
• Assist in training of employees.
• Review of employee training records to ensure compliance with all applicable policies. Report any issues uncovered.
• Ensure that job and cGMP training is completed, documented and on file.
• Review & receive soft good and supply shipments.
• Assist Quality Managerin assuring performance of all validation protocols.
• Verify that calibration requirements for new equipment and those returned from service are performed prior to use.
• Verify that calibration, quality control, and maintenance is performed according to requirements.
• Release soft goods (verification of stock rotation).
• Be available and an integral part of all inspections.
• Assure that re-training of employees is effective and complete on all non-compliant issues.
• Make suggestions for changes in SOP as needed.
• Assist in resolving errors, issues, and non-compliance at a center.
• Assist the Quality Manager in evaluating all errors that occur during manufacturing (includes those identified before release of plasma).
• Supplies and reagents (manufacturer, lot number, expiration date, receipt date, disposition of rejected supplies and reagents).
• Ensure timely reports to CBER of errors/accidents that could affect the safety, purity, identity or quality of product.
• Report Emergency Situations immediately.
• Must be able to monitor and implement all quality initiatives and ensure strong regulatory compliance to all established policies/procedures at the center.
• Report monthly to Director of RA/QA
• Accept other assignments as delegated by Manager.
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
• Any other duties as assigned.

• High School Diploma or Equivalent
• Current CPR card
• One year experience in a donor center with similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience preferred
• Certified in Reception Area, Plasma Processing and Donor Collection Area (within six months of being assigned as Q.A. Coordinator).
• Successfully complete the required Q.A. training program.
• Organizational and communication skills required.
• Must have legible handwriting.
• Must be able to use a computer and have knowledge of mathematics.
• Be able to work independently and multi-task effectively.

Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel…