Immucor Quality Jobs

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Job Information

Immucor, Inc. Quality System Specialist in Atlanta, Georgia

Overview

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together.

Due to our continued growth, we are seeking a results-oriented and experienced Quality System Specialist to join our team. In this position, you will play a key role reviewing all device history record documentation to ensure compliance to all applicable regulatory standards. This will involve using your detail-oriented abilities and knowledge of standard concepts, practices and procedures to provide quality input. If you have a solid background working in a comparable manufacturing environment, and the analytical capabilities that this position requires, we want to hear from you. Contact us today!

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Quality Assurance System Specialist (Manufacturing Compliance / Systems QA)

Responsibilities

As a Quality System Specialist, you will be responsible for reviewing and approving all documentation for serological, chemical and biological evaluations to ensure the product meets specifications prior to distribution. This will include evaluations completed on final, intermediate and raw material products and for filling, labeling and packaging operations.

Specific duties for this manufacturing operations compliance role include:

  • Performing batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives

  • Ensuring accuracy, integrity and completion of every page, reconciliation, and product yield computation

  • Identifying mistakes, oversights, and incomplete data on batch records and reporting batch record deficiencies to Manufacturing for correction

  • Understanding regulatory requirements thoroughly, including domestic and international standards applicable to our company, and the consequences of nonconformance

  • Writing standard operating procedures, change orders, document change requests, and corrective/preventive action requests

  • Maintaining a thorough understanding of our company policies and basic understanding of activities of all company departments

  • Representing our Sr. Quality Operations Managers and/or Quality Operation Managers in a variety of forums, as deemed necessary

  • Efficiently making quality decisions to include determination of a quality deviation, Product hold and disposition, etc. based on the specific circumstances that could affect product quality

Quality Assurance System Specialist (Manufacturing Compliance / Systems QA)

Qualifications

We are looking for a highly organized and detail-oriented Quality System Specialist who combines exceptional analytical and problem-solving skills with the ability to quickly drive solutions while maintaining positive relationships. In addition, you should be able to work independently to manage and prioritize your workload and assignments within a fast-paced manufacturing environment. It is also important that you display excellent verbal and written communication skills, as well as the ability to effectively build working relationships both internally and externally at various organizational levels of the organization.

Specific qualifications for this medical device quality assurance role include:

  • Bachelor’s degree in medical laboratory science

  • 5+ years of experience in a comparable manufacturing environment to ensure sound judgment and performance

  • Computer proficiency including MS Office Suite

  • Intermediate mathematics skills

  • Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485, as well as Canadian Medical Devices Regulations, and In-Vitro Diagnostics Directive

  • Ability to adhere to Regulatory and Compliance Standard operating procedures

  • Experience and/or certification as a medical technologist, preferred

Quality Assurance System Specialist (Manufacturing Compliance / Systems QA)

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; DRUG FREE WORKPLACE

RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Immucor offers a comprehensive benefits package available on the start date of your employment, including:

  • Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents

  • Wellness program

  • STD/LTD/Life insurance all 100% company paid

  • Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents

  • Tuition reimbursement

  • Company matched 401k plan

  • Vacation/Company & Personal Holidays/Sick days

Job Locations US-GA-Atlanta

Job ID 2021-2715

Category Quality


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