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LifeSciences Quality Systems Engineer
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 LifeSciences Quality Systems Engineer is responsible for monitoring and enhancing the overall effectiveness and regulatory compliance of the quality management system of LNH Life Sciences. Manages, monitors, and enhances the effectiveness of all aspects of Life Sciences complaint investigations, nonconformances, and/or equipment out of tolerance investigations. Provides overall support to maintaining the quality management system, including performing internal quality audits and assisting with 2nd and 3rd party audits of LNH Life Sciences and Biologics. Leads formal problem resolution teams. Facilitates and provides initial and ongoing GMP training for LNH employees.
What you'll do:
- Program/Process Development: Facilitates the initial development and ongoing monitoring of the LifeSciences Good Manufacturing Practices (GMP) quality management system utilizing sound project management principles. Creates and revises standard operating procedures consistent with applicable standards regulations, and guidelines. Ensures related project tasks are monitored for completion according to established schedules.
- Investigation Management/Problem Resolution: Evaluates complaints, nonconformances, and/or equipment out of tolerance investigations to determine appropriate level and type of response, as well as to ensure thorough root cause analysis and effective corrective actions are executed. Leads teams to resolve problems using formal methods, such as 8D. Provides coaching to Life Sciences personnel on selecting and executing appropriate problem resolution concepts.
- Training: Develops and provides training to Life Sciences personnel on GMP, investigation management, and use of QMS related applications (e.g., CATSWeb, MasterControl, etc.)
- Audits: Facilitates the performance of internal quality audits of Life Sciences activities to ensure procedural compliance and effectiveness. Manages and fulfills requests for completion of supplier desktop audits, surveys, and questionnaires pertaining to Life Sciences Quality. Assists with 2nd and 3rd party audits of LNH Life Sciences and Biologics. Reviews audit reports and assists with follow-up of findings from auditing entities.
- KPIs: Establishes, monitors, and analyzes key performance indicators related to Life Sciences investigation management, audits, GMP program development and other related areas of focus. Recommends and initiates process improvements based on trends identified. Manages and evaluates CAPA trending data effectively.
- Product Inspection: Develops, enhance, and monitors systems for returned product inspections for Life Sciences products. Tracks and trends final inspection results and returned graft inspections.
What you'll bring (Minimum Requirements):
- Bachelor's Degree
- FOUR (4) years – Experience in Quality or operations-related activities in Life Sciences, pharmaceutical, tissue banking, medical device, or clinical trial
- GMP Training Certification – Current or obtain within first two years of start date in role
- Project Management Certification – Certified Associate in Project Management (CAPM) or Project Management (PMP) – current or obtain within one year of start date in role
Preferred Experience/Skills/Certifications:
- Bachelor of Science – Life Sciences, Engineering, Biological Sciences, Allied Health field or Policy Administration
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
- Proficient in MS Office – PowerPoint, Excel, Word, Outlook, Microsoft Suite
- Statistics – Demonstrates a working knowledge of statistical analysis
- Attention to Detail – Able to perform tasks thoroughly with care; checks work to ensure high degree of accuracy/completeness and early/on-time delivery
- Problem Resolution – Demonstrates ability to anticipate and critically think through problems
- Analytical Thinking – Able to successfully gather and evaluate pertinent information to draw conclusions and identify potential trends.
- Time Management – Able to prioritize multiple competing priorities and manage time/workload. Demonstrated ability to effectively prioritize and juggle multiple time sensitive projects, multi-task, identify project interdependencies and potential risks/pitfalls.
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 candidate's 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.
