Immucor, Inc. Quality Operations Associate in Warren, New Jersey
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.
We are looking to hire a Quality Operations Associate to join our Quality Assurance team. This position is responsible for quality assurance activities under the direction of the Sr. Manager, Quality Operations. As the Quality Operations Associate you will receive and perform Batch Record Review, as well as assisting in the development and preparation of such documents and records. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply 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 Associate (Quality Assurance)
As a Quality Operations Associate you will function as part of a team. The team is responsible for coordinating and executing, in a timely fashion, all activities necessary to maintain compliance and toensure that the company maintains compliance with applicable external regulations and internal quality system requirements.
Additional responsibilities include:
Perform line opening and closing in support of manufacturing operations.
Perform inspection and documentation review of incoming components, in process product and finished product in the manufacturing areas to ensure compliance
Perform duties for the reception, sampling, issuance and inventory of raw materials, components and product
Initiate or assure initiation of product holds and/or deviations. Assist in the investigation of such occurrences
Perform product releases to Finished Goods both physically and electronically as needed
Review and approve incoming, in-process and final batch records (DHRs); ensure associated NCMRs are processed per procedural requirements; maintain retain program; maintain QA inventory; perform necessary ERP transactions
-Maintain NCMR and Deviation subsystems
Assist in drafting and review of design and validation documentation.
Maintain filing archives for all job-related quality records to ensure controlled access is maintained at all times.
Maintain Employee Training program and conduct training activities, as required
Trend quality metrics and present data to manager quarterly.
Maintain quality system compliance with ISO 13485, QSR & IVDD, including creating new/revising existing quality system documentation
Other duties as required.
-Remain up-to-date with current federal and international regulations and industry trends as related to the above listed duties.
- Conduct required new hire and current employee training activities and maintain training matrix and database
Quality Associate (Document Control – Quality Control)
To be successful in this Quality Operations Associate role, you must have exceptional organizational skills with a keen eye for detail in proofreading tasks. An ideal candidate for this role can receive direction well and work independently.
Additional requirements of this role include:
Bachelor’s degree or equivalent, or 6 months to 1 year of related experience
Exceptional organizational skills
Ability to proofread controlled documents with a keen eye for detail
Excellent verbal and written communication skills
Familiar with Microsoft Excel, Word, Access, and Outlook
Quality Associate (Quality Assurnace)
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.
Job Locations US-NJ-Warren
Job ID 2021-2588