What are the responsibilities and job description for the Quality Assurance Lead position at LifeNet Health?
Quality Assurance Lead
Location: Kalamazoo, MI
Department: LifeSciences - Operations
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 Quality Assurance Lead is responsible for ensuring that laboratory operations comply with GLP standards through comprehensive and timely internal quality audits that are effective, on schedule and meets all regulatory requirements. This position supports the compilation and review of Life Sciences laboratory control records. This position ensures compliance of quality systems for the Assay Services Lab Operations, including overseeing non-conformances, CAPAs, change control processes, computer system compliance. This role involves maintaining document and record control, approving quality related decisions. This position supports the overall business operations by driving process improvements using analytical and LEAN principles to support business operations and resolve quality issues. Leads all external audits. Reviews and approves study protocols and assures all deviations are corrected. Provides Quality and compliance training to Laboratory staff.
What you’ll do:
- Audits: Performs all facets of internal GLP quality/process audits, including plan development, initiation, observations/interviews, analysis of results, report compilation/distribution, presentation of results to auditees, approval and verification of corrective/preventive actions, and audit file maintenance. Partners to set up study initiation meetings and establish a master schedule. Performs periodic reviews of logbooks and laboratory operations to ensure compliance. Works with the Study Director to coordinate study-related audits. Performs protocol, laboratory notebook, data transfer, record, report, and archival reviews. Works with Laboratory management to maintain Master Schedule.
- 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. Complete GLP, QA, Audit, and SciNote training. Reviews all GLP study protocols and final reports for compliance. Provides guidance and training to LifeSciences personnel on documentation requirements, regulatory compliance, and industry best practices.
- Document and Record Control: Prepares and reviews quality documents and summary reports required by agreement for contract companies. Act as “GLP Archivist” to maintain records (equipment, training, audits, etc.). Provide guidance and training on GDP for site personnel and record management for back-up archivists.
What you’ll bring (Minimum Requirements):
- Bachelor’s Degree
- FOUR (4) years’ experience in quality or operations related activities in tissue banking, blood banking, medical device, clinical trial, or pharmaceutical.
- TWO (2) years’ experience in leading internal quality audits in a tissue bank or medical device related industry, to include all elements of a standard quality management system (QMS)
- TWO (2) years’ experience in leading quality audits of external entities
Preferred Experience/Skills/Certifications:
- ASQ – American Society of Quality Certification
These would be nice too (Knowledge Skills and Abilities):
- Industry regulations, standards, and guidelines
- Communication skills
- Problem resolution
- Technical writing
- Analytical thinking
- Attention to detail
- Proficient in MS Office
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
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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.
Salary : $65,972 - $87,962
