Quality Assurance Coordinator

DescriptionQuality Assurance Coordinator, Life SciencesLocation: Kalamazoo, MIDepartment: LifeSciencesJob Type: Full-TimeShift: Mon. - Fri.: 8:15AM - 5:00PMLifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.How You Will Contribute To LifeNet Health''s SuccessThe Quality Assurance Coordinator, LifeSciences serves as a member of the Kalamazoo LifeSciences team and is responsible for the compilation and review of LifeSciences batch production and laboratory control records. This position will serve as a subject matter expert for LifeSciences production documentation and will provide guidance and training to LifeSciences personnel on requirements associated with completing quality records.What You''ll DoReview and Compilation: Compiles and reviews batch production and laboratory control records of critical process steps of varying levels of complexity for accuracy and completeness. Performs product release, tissue movement and quality hold functions as applicable in corresponding application. Investigations: Initiates, reviews, and assists with the completion of nonconformance and complaint investigations. Maintains and monitors system for tracking investigations impacting the release of batches. Process Improvement/SOPs: Using LEAN principles, identifies mechanisms to strengthen and improve process controls related to record review functions and takes necessary measures to execute required actions. Creates and revises standard operating procedures and forms for the LifeSciences Division.Document Review: Prepares and reviews quality documents and summary reports required by agreement for contract companies. Training: Provides guidance and training to LifeSciences personnel on documentation requirements, regulatory compliance, and industry best practices.What You''ll Bring (Minimum Requirements)Bachelor''s Degree in Chemistry, Biology, or other related degreeThree (3) years experience in pharmaceutical, tissue banking, medical device, laboratory, Life Sciences, or health care related environment Three (3) years experience reviewing batch records or other quality records, or performing general quality systems related activitiesThese Would Be Nice Too (Knowledge Skills And Abilities)Industry regulations, standards, and guidelines: Able to review requirements, determine relevance to processes within the organization, and ensure compliance as applicableCommunication Skills: Written, verbal and presentation; ability to engage, inspire and influence peopleProblem Resolution: Experience to anticipate and critically think through problems. Advanced knowledge problem resolution tools Technical Writing: Able to create and revise documents, presentations and training materials according to established requirementsAnalytical Thinking: Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trendsAttention to Detail: Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time deliveryMicrosoft Office: Proficient in Microsoft Office and Adobe ProWhy work at LifeNet Health?We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won''t find another company with a culture as strong as ours.403(b) and Pension PlanMedical, dental, and vision coverageCorporate sponsored events Work-life balance with generous paid time offTuition reimbursementPersonal career and skill development opportunitiesWellness ProgramEmployee Assistance Program (EAP)Dedicated and passionate co-workersWe are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Created: 2025-10-04