Senior Quality Systems Specialist, LifeSciences

Location: Virginia Beach

Department: LifeSciences Quality Systems

Job Type: Full-Time

Shift: Monday-Friday, Full Time

Clinical Classification: Non-Clinical

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 Senior Quality Systems Specialist serves as a member of the Quality Unit and is responsible for the development and/or continuous improvement of LifeSciences batch production documents (e.g., cell production) and laboratory control documents used for capturing essential process data. This position is responsible for the compilation and review of LifeSciences laboratory control records and supports overall business operations by utilizing an analytical approach to problem resolution and conducting quality unit inspections in accordance with internal SOPs, contracts, voluntary accreditation standards and applicable government regulations.

What youll do:

• Quality Assurance: Performs assigned quality assurance unit duties as defined in applicable regulations, guidelines, standards, and internal procedures (e.g., Good Manufacturing Practices, Good Laboratory Practices, etc.) Supports development, enhancement, alignment, and maintenance of the LifeSciences quality management system (QMS) in accordance with prescribed timelines and desired outcomes.
• Document Review/SOPs: Reviews quality records required by regulation, standard, procedure or agreement with contract companies to confirm proper completion. Creates and revises standard operating procedures and other quality documents for the LifeSciences Division. Performs LifeSciences Quality reviews of Document Change Orders (DCOs) and Management of Change (MOCs) tasks for approval.
• Quality Audits: Performs internal quality audits of LifeSciences activities and other QMS elements shared across divisions. Serves as an independent auditor of assigned functions outside of the division as directed by senior leadership. Supports preparation and execution activities for 2nd and 3rd party audits of LifeNet Health. Performs design history file (DHF) audits for LifeSciences products.
• Process Improvement: Using Lean principles, identifies mechanisms to strengthen and improve process controls related to LifeSciences and takes necessary measures to execute required actions. Provides Quality support on cross-functional project teams and process improvement efforts.
• Training Collaborates with QS leadership and key stakeholders to develop and maintain LifeSciences Quality training curricula and materials. Provides guidance and executes training on curriculum content for LifeSciences personnel. Conducts and/or ensures completion of annual GMP and GLP training. Maintains metrics associated with LifeSciences Quality training requirements and completion status.

What youll bring (Minimum Requirements):

• Bachelors Degree
• FIVE (5) years Experience reviewing batch records or other quality records, or performing general quality systems related activities (including auditing, investigation management or document control) in a pharmaceutical tissue banking, medical device, laboratory, LifeSciences, or healthcare related environment
• GMP Training Certification current or obtain within first two years of start date in role

Preferred Experience/Skills/Certifications:

• Bachelors Degree Chemistry, Biology, or other scientific field
• TWO (2) years Experience in GMP and/or GLP quality within an FDA regulated industry (i.e., cell therapy, biologic, pharmaceutical, or medical device industry)
• ONE (1) year Experience with Lean manufacturing concepts & tools (value stream mapping, 5S, Kaizen events)
• CPGP Certification - ASQ Pharmaceutical GMP Professional

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 excellent verbal and written communication skills; ability to communicate and build relationships with all professionals at different levels within the organization
• Problem Resolution demonstrates ability to anticipate and critically think through problems
• Technical Writing Able to create and revise documents, presentations and training materials according to established requirements
• Analytical Thinking able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.

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: $65,972 - $87,962/annually*

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. #LI-FJ1

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