QA Document Control Specialist

About the role

Join our Quality Assurance team in Columbia, Maryland, where your attention to detail and commitment to excellence will help ensure life-changing products reach patients safely and efficiently. This is an exciting opportunity to support manufacturing operations in a highly regulated environment while contributing to scientific and medical advancements that improve lives.

Responsibilities

• Issue batch production records and product labels to manufacturing in line with production schedules
• Assign product lot numbers and perform inspection of batch records associated with manufacturing processes
• Generate, review, and inspect complex product labeling, identifying even minor defects on printed labels
• Prepare printing and inspection documentation in accordance with established procedures and good documentation practices
• Coordinate printing activities to ensure manufacturing operations have the records and labels needed to maintain production flow
• Support compliance with 21 CFR 1271 requirements and current American Association of Tissue Banks standards
• Scan, file, archive, and maintain quality records and controlled inventory documentation
• Prepare, verify, and manage quality records for off-site storage

Requirements

• Associate's or Bachelor's degree, preferably in a science-related field
• Minimum 1 year of experience working in a regulated environment such as GMP or GTP
• Minimum 1 year of experience in a detail-oriented inspection role of any kind
• 1–2 years of experience performing document control functions or printing and inspecting large quantities of labels
• Strong attention to detail with the ability to perform repetitive inspection activities accurately and consistently
• Experience in document control, label printing, label inspection, or other detail-focused quality inspection activities preferred
• Ability to work independently in a fast-paced environment while managing changing priorities
• Strong communication, decision-making, and problem-solving skills
• Working knowledge of quality systems and manufacturing or tissue practice standards
• Ability to sit for extended periods, perform visual inspections, and lift boxes weighing up to 40 pounds

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Purchase Plan
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical, Dental, and Vision coverage
• Health Savings Account (Employer Contribution of $500+ annually)
• Employee Assistance Program
• Parental Leave
• Fertility and Adoption Assistance Program
• Hybrid Work Model (for most professional roles)
• Hands-on, team-customized training and mentorship
• Discounts on fitness clubs, travel, and more

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.