Smith+Nephew ยท 4 days ago
QA Associate II
Columbia, MD
Full-time
Hybrid
Entry Level
$48K/yr - $72K/yr
2+ years expSmith+Nephew is a company that designs and manufactures technology to enhance living. The QA Associate II is responsible for reviewing production control records and associated documentation for manufactured tissue products, ensuring compliance with quality standards.
Medical Device
Responsibilities
Review of supplemental documentation associated with tissue product production performed, including label records, environmental monitoring records, cleaning records, quality control testing records, autoclave records, and donor eligibility records
Review and evaluation of tissue product production records for disposition
Maintenance and reporting of the production record review metrics
Scanning, filing, and archival of QA related documents
Qualification
Required
Minimum of a bachelor's degree in Life Sciences or science-based field
At least 2 years of experience in a regulated biotechnology or pharmaceutical environment in a quality role
1 - 2 years of experience performing batch record review or manufacturing using batch records at a regulated biotechnology or pharmaceutical company
A basic understanding of Good Tissue Practices (GTP) or Good Manufacturing Processes (GMP) and Quality Systems
A working knowledge of Microsoft Office applications
Ability to work independently and with cross-functional teams to facilitate progress and meet timelines and metrics
Ability to pay continuous attention to detail, including documentation of procedural details when performing repetitive critical tasks
Excellent interpersonal and communication skills inside and outside of the department
Physical Demands: Office area, warehouse area, controlled temperature storage areas, be able to lift at least 50 lbs
Preferred
1 - 2 years in Quality performing batch record review and disposition of products at a regulated biotechnology or pharmaceutical company
Benefits
Medical, dental, and vision coverage
401k
Tuition reimbursement
Medical leave programs
Parental leave
Generous PTO
Paid company holidays annually
8 hours of Volunteer time
Wellness offerings such as EAP
401k Matching Program
401k Plus Program
Discounted Stock Options
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Fertility and Adoption Assistance Program
Hybrid Work Model (For most professional roles)
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more
Company
Smith+Nephew
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Katerina Dodbiba
SVP, CFO Orthopaedics, Sports Medicine & ENT
Pierre Palassian
SVP, CFO Global Operations, Quality and Regulatory Affairs
Recent News
2025-10-06
2025-10-03
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