Senior Quality Systems Specialist, LifeSciences

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 Health’s 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 you’ll 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 you’ll bring (Minimum Requirements):

• Bachelor’s 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: