Quality Systems Associate

Summary

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

• 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 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.
• Affords assistance to the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.

Duties

• 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 Duties

• Affords assistance to 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.

Additional Responsibilities

• 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.

Knowledge, Skills, And Abilities

• 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.

Education

• High school diploma or GED.

Experience

• Typically requires no previous related experience.

Occupational Demands

• 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.
• Able 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 at waist.
• Light lifting of 15lbs. with a maximum lift of 50lbs.
• May reach below shoulder height.
• Hearing acuity essential.
• Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Works independently with little guidance or reliance on oral or written instructions.
• Performs a wide range of tasks as dictated by variable demands and changing conditions.
• Relates sensitive information to diverse groups.