Quality Assurance Specialist

2 weeks ago

Akron, Ohio, United States GRIFOLS, S.A. Full time

Job Title: Quality Systems Associate

Job Summary:

Grifols is seeking a Quality Systems Associate to join our team in Akron, OH. As a Quality Systems Associate, you will be responsible for ensuring compliance with internal and external regulations and protocols. You will perform quality assurance and training functions, including reviewing equipment QC and maintenance records, documenting and investigating deviations and customer complaints, and inspecting and releasing incoming supplies.

Key Responsibilities:

  • Completes weekly review of equipment QC and maintenance records.
  • Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
  • Inspects and releases incoming supplies.
  • 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.
  • 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 proper freezing, storage, and handling of product.
  • Assists the Quality Systems Manager to ensure center training programs follow procedural requirements.
  • Creates, maintains, and audits training records and files to ensure compliance.
  • Performs employee training observations to ensure staff competency.
  • Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.

Requirements:

  • High school diploma or GED.
  • Obtains state licensures or certifications if applicable.
  • Typically requires no previous related experience.

Work Environment:

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.

Physical Demands:

  • 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 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.

Equal Employment Opportunity:

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law.

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