DQA Analyst

Posted Date 1 month ago(6/4/2020 8:08 AM)
Job ID
2020-2430
Job Location
US-GA-Kennesaw
# of Openings
1
Category
Quality Assurance

Introduction

Is This The Role For You?

 

We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

 

If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

Position Overview

To coordinate the activities necessary to ensure that all donor records flow through the system with minimal delay.  Provide a leadership role for entry level DQA individuals.    Ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner.

Responsibilities

  • Complete Release Review for donor records that have completed Medical Director Review was per QA0002 and QA0066.
  • Review incoming information after donor release to assess for impact on released tissues as per QA0065.
  • Read, critique, review and complete DQA form reviews per QA0175, QA0176 and QA0079 as delegated by DQA Management.
  • Read, critique, review and recommend the intermediate disposition of all donor records daily.
  • Ensure that donors with status of Pending Complete and Pending Reject are properly identified, controlled, and meet the required quality specifications for discard prior to chart completion.
  • Ensure completion of the Donor Record Review for DQA per QA0090 within timelines established by Microbiology team.
  • Scanning of Certificates of Assurance as requested by Management.
  • Review donor charts for acceptability for enrollment in studies as per QA0087.
  • Develop systematic methods for completing work assignments to ensure timelines are met and personal job commitments are accomplished.
  • Understand ISO requirements, AATB, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
  • Have the ability and interest in being on the job every day as required by current attendance policies.
  • Effectively complete “other” functions that may be assigned.
  • Implementation of policies, procedures, and practices necessary to meet all state, federal and international requirements for CryoLife products.
  • Ability to work as a team member to achieve Corporate goals and present idea that are motivating thereby maintaining positive support from fellow team members.

Qualifications

 

  • Bachelor's degree, preferred in biological sciences
  • Good relationship skills
  • Attention to detail
  • Use of personal computer, utilizing word, excel programs
  • Must have a high degree of stability, good emotional control, excellent expression (oral and written), and must be a goal-oriented team player.
  • Analytical skills for considering all pertinent factors, making decisions quickly and carefully and accepting responsibility for those decisions.
  • Must be a self-starter, alert for situations requiring action, confident of being able to think situations through, and possess the ability to work independently with minimal supervision.
  • Must be able to maintain a high activity level and be able to effectively manage and prioritize numerous projects and responsibilities.
  • Must be legally authorized to work in the United States
  • Must be willing to submit to a pre-employment background check and drug screen
  • Must be at least 18 years of age

Company Info

Who We Are.

 

CryoLife is one of the world’s leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.

 

CryoLife is an Equal Opportunity/Affirmative Action employer.

 

CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

 

Reasonable Accommodations

 

CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

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