Immucor, Inc. Supervisor, Quality Control Laboratory 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 Supervisor, Quality Control Laboratory. This key role is responsible for supervising the activities of the Quality Control Department ensuring that raw material and final products are tested on time and meeting all applicable procedures and specifications.
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 Control - Supervisor
As the Supervisor, Quality Control Laboratory, you will be responsible for ensuring the technical adequacy of activities performed at the QC Laboratory inclusive but not limited to: raw materials, in-process, final product and stability testing, )OS investigation, deviations, and NCMRs issuance, review and approval. Ensure that the Stability Program meets all the established time point testing requirements. Provide direction and guidance to the QC laboratory staff in the performance of daily laboratory operations such as testing, equipment maintenance and calibrations, supplies and reagents inventory and record keeping in conformance with applicable regulations. Serve as a subject matter expert, coach, and mentor to the other laboratory staff.
Essential Duties and Responsibilities
Provides direction to the laboratory staff in the performance of daily tasks. Ensuresthat department employees follow all applicable regulatory and safety requirements.
Reviews/approves as needed, laboratory records for completeness, technical accuracy, and acceptability of results and for conformance to written specifications, SOPs, and applicable regulations (inclusive but not limited to: FDA, Health Canada, ISO 13485, OSHA, etc.).
Schedules laboratory activities to meet production requirements.
Establishes the appropriate structure to support the on-market as well as specialstability requirements in support of validation or other applicable study protocols. Prepares required protocols and procedures for stability studies as needed.
Ensures timely completion of out-of-specification records, root cause analyses,and deviations investigations.
Implements key performance metrics to monitor and improve the laboratoryactivities efficiencies and compliance.
Implements continuous improvements initiatives to increase laboratory efficiencies such as elimination of redundant tests, 5S, kanban, balanced workload, etc.
Manages employee training activities including appropriate training records.
Performs employee appraisals.
Timely identifies and documents, under the direction of Human Resourcesdepartment, the need for any employee intervention inclusive of disciplinary actions.
Assists in the establishment of a succession planning process for laboratories key functions.
Assists with the preparation of department budget and keeps expenses withinestablished limits.
Interacts cooperatively with coworkers, supervisors, or managers of otherdepartments and receives direction well from superiors.
Performs other duties as assigned by the Associate Director, Quality Operations.
Quality Control - Supervsor
We are looking for a Supervisor, Quality Control Laboratory with a blend of strong leadership and technical skills including day-to-day management of activities in line with corporate objectives and priorities, resource management inclusive of associate performance management, and strategy development related to the support role and the function this team provides.
Specific qualifications for this role include:
Bachelor's degree in related industry (chemistry, biology, immunology, etc.)
4 to 10 years related experience and/or training, including cGMP experience or experience in a regulated environment
Previous medical device and / or IVD experience, required
Supervisory experience in the field with effective managerial skills to lead and supervise a team
Working knowledge of 21 CFR820, ISO 13485, IVDD
Medical Technologist, ASCP SBB certification, BS Clinical Laboratory Sciences, preferred
Ability to influence others to perform their jobs effectively and to be responsible for making decisions and problem solving
Ability to focus on a goal and obtain a pre-determined result
Demonstrated proficiency with Microsoft Suite products
Quality Control - Supervisor
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
STD/LTD/Life insurance all 100% company paid
Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents
Company matched 401k plan
Vacation/Company & Personal Holidays/Sick days
Job Locations US-NJ-Warren
Job ID 2021-2724