Quality Systems Coordinator, Life Sciences
Location: Virginia Beach, VA
Department: Quality Systems
Clinical Status: Non-Clinical
Job Type: Full-Time
Shift: Mon. Fri.: 8:15AM 5:00PM
LifeNet 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 Healths success:
The LifeSciences Quality Systems Associate serves as a member of the Quality Unit 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 youll do:
- Review 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 youll bring (Minimum Requirements):
- Bachelors Degree Chemistry, Biology, or other Scientific field
- THREE (3) years pharmaceutical, tissue banking, medical device, laboratory, Life Sciences, or health care related environment
- THREE (3) years experience reviewing batch records or other quality records
These 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 applicable
- Communication Skills: Written, verbal and presentation; ability to engage, inspire and influence people
- Problem 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 requirements
- Analytical Thinking: Demonstrates the ability to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends
- Attention to Detail: Able to perform tasks thoroughly and with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
- Microsoft Office: Proficient in Microsoft Office and Adobe Pro
Why work at LifeNet Health?
We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You will not find another company with a culture as strong as ours.
- 403(b) and Profit-Sharing Plan
- Affordable medical, dental, and vision coverage
- Corporate sponsored events for employees
- Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays
- 18 vacation days
- 9 sick days
- 7 paid holidays
- Tuition reimbursement
- Personal career, skill, and leadership development opportunities
- Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)
- Employee Assistance Program (EAP) for employees and members of their household
- Dedicated and passionate co-worker
Salary: $20.36 - $27.15/hourly
The pay rate for the successful candidate will depend on geographic location and the candidates qualifications and prior relevant experience. * Actual compensation may be higher based on the successful candidate's knowledge and relevant experience.
This position is eligible for an annual bonus once eligibility criteria are met.
All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law. Further, nothing in this posting is intended to alter the at will relationship of a successful candidate and this posting does not constitute a specific promise.
LifeNet Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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