Quality Systems Associate

Under the direct supervision of the Quality Systems Manager perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.

Primary responsibilities for role (level-specific responsibilities should be included in the chart below):

• Completes weekly review of equipment QC and maintenance records.

• Documents investigates and performs root-cause analysis for deviations and customer complaints specifically in how they related to product quality and/or donor safety.

• Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.

• Performs documentation review for unsuitable test results.

• Assists the Quality Systems Manager to ensure that cGMP regulation SOPs and regulatory requirements are followed. Duties include:

• Under the direct supervision of the Quality Systems Manager perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.

• Performs all product release activities.

• Reviews lookback information and documentation.

• Reviews waste shipment documentation.

• Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.

• Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.

• Reviews donor deferral notifications from competitor centers.

• Reviews plasma processing documentation to ensure the proper freezing storage and handling of product.

Quality Systems Associate

• Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include:

• Creates maintains and audits training records and files to ensure compliance.

• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.

• Conducts required training activities for Center Notifications Corporate Directives SOP changes and initial SOP implementations.

• On an occasional basis when the Quality Systems Manager is absent the Quality Systems Associate may be required to perform the following duties:

• Reviews and approves of deferred donor reinstatement activities.

• Assists with completion of the internal donor center audit.

Summary:

• Performs review of monthly trending report.

• Performs review of donor adverse events reports and the applicable related documentation.

• Conducts training to address donor center corrective and preventative measures.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties responsibilities or requirements. Managers and supervisors may assign other duties as needed.

Additional Responsibilities:

Is certified and maintains certification as a Donor Center Technician.