Quality Systems Associate

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.

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically how they relate to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies that 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.
• 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.

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.

• 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 deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.

• Is certified and maintains certification as a Donor Center Technician.

Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols.

Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail.

High school diploma or GED. Obtains state licensures or certifications if applicable.

Typically requires no previous related experience.

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day.

The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion.

Occasionally walks, bends and twists ht lifting of 15lbs. with a maximum lift of 50lbs.…