Immucor, Inc. Quality Assurance Specialist in Norcross, Georgia
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.
The Quality Assurance (QA) Specialist will assist the Sr. Quality Operations Manager in the maintenance, archiving and retrieval of documentation and data as they pertain to Quality Assurance deliverables including but not limited to Quality Review Board (QRB), Management Review Board (MRB) and change control projects. The Quality Assurance Specialist may also assist in the development and preparation of reports, presentations and assist with training and cross training of other staff on the Quality Assurance procedures.
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 .
Executes and effectively communicates lean principles and tools to promote quality achievement and performance improvement throughout the facility.
Serves as subject matter expert (SME) for quality systems (i.e., Deviation Management, Corrective and Preventive Actions (CAPA), Trending, Change Control etc.
Performs root cause analysis and implements CAPAs for quality related concerns.
Leads continuous improvement activities (5S, Kaizen, etc.) to enhance the execution of quality processes across all assigned operations.
Identifies and implements quality key performance indicators, develop benchmarks, measurements, quantifiable benefits and track progress for areas of responsibility.
Fosters a continuous improvement culture by partnering with other organizations in alignment with Quality strategic objectives.
Reviews and approves documentation including but not limited to OOSs, deviations, root cause investigations, CAPAs, protocols, reports, procedures, change orders, etc.
Participate in the development and maintenance of change control workspaces, for proofing, filing, copying, scanning, archiving and retrieval of relevant change order documentation.
Serve as custodian for all QRB/MRB data, presentations and controlled Change Control documents until they are archived by the Document Control department.
Responsible for gathering QRB/MRB data from responsible departments and for processing Change Control Requests for Change Controls submitted throughout the Norcross campus.
Provide on-going interactions with all functional groups to improve product quality and compliance throughout the Change Control process.
Conduct readiness assessments, evaluate results and present findings in a logical and easy-to-understand manner.
Assists with the oversight and coordination of the Change Control program. Interact with management as necessary to accomplish projects goals and objectives.
Identifies and escalates as appropriate, issues that may arise during the various stages of the Change Control process (i.e. from analysis and design through to adoption)
Identifies deviations in performance from the Change Control procedures and assist with strategies for corrective action to achieve full compliance with organizational changes.
Creates and distributes weekly Change Control update notifications and schedules appropriate individuals as needed to attend weekly Change Control meetings.
Creates queries for controlled document auditing and to address document inquiries, as requested.
Creates and maintains Change Control tracking spreadsheet for all in process Change Controls.
Provide quality oversight of the assigned area to address immediate quality issues, work to improve the quality of the process, using data collected from the operations and applying problem-solving techniques.
Serve as a liaison to the Supplier Quality and/or internal audit teams, as appropriate.
Additional Responsibilities Include :
Assist Quality Management Team in establishing, implementing and maintaining the quality management system.
Assist Quality Management Team in improving Immucor's Quality Systems
Formulate and maintain quality objectives complementary to company policies and goals
Bachelor's degree (BA/BS) from a four-year college or university
Quality certification, such as CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor), preferred, but not required
Ability to develop credibility with employees and management
Sound judgment and decision making skills
Strong time management, multi-tasking and all round communication skills
A self-manager who is productive, takes initiative and seeks opportunities for improvement
Effective presentation/communication skills, project/resource management skills
Ability to work independently and in a team environment
Ability to manage frequent computer/report work, and administration of quality system programs and resources.
Proven track record of demonstrated problem solving and root cause analysis skills
In-depth technical experience in the respective operational area - Laboratory Controls and Batch Release
Knowledge and experience in overall GxP and Compliance processes
Knowledge and experience in facility and equipment/instrument routine maintenance - related to Laboratory Controls
Job ID 2019-1943