QA Label Specialist

Smith+Nephew; Columbia (MD); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid Work Model

401k Matching

Tuition Reimbursement

Paid Holidays

Health Benefits

Job summary

Smith+Naphew is seeking a Quality Assurance specialist in Columbia, Maryland to support manufacturing operations in a highly regulated environment. You will inspect batch records, printing, labeling, and documentation to ensure compliance and product safety for patients.

Ideal candidates have 1+ year in GMP/GTP settings, strong attention to detail, and experience in document control or label inspection. Hybrid work arrangement offered to most professional roles.

Qualifications

• Associate's or Bachelor's degree, preferably in a science related field.
• Minimum 1 year of experience in a regulated environment (GMP/GTP).
• Minimum 1 year in a detail oriented inspection role.
• 1–2 years in document control, label printing or large-label inspections.
• Strong attention to detail and ability to perform repetitive inspection tasks accurately.

Responsibilities

• Issue batch production records and product labels aligned with production schedules.
• Assign product lot numbers and inspect batch records from manufacturing processes.
• Generate and inspect complex product labeling and identify minor defects on labels.
• Prepare printing and inspection documentation per procedures and GDPs.
• Coordinate printing activities to maintain production records and labels.
• Support compliance with 21 CFR 1271 and tissue bank standards.

Skills

Detail oriented

Communication

Independent work

Problem solving

Decision making

Education

Associate's degree

Bachelor's degree

Job description

Life Unlimited. At Smith+Naphew we design and manufacture technology that takes the limits off living.

Are you passionate about quality, compliance, and making a meaningful impact in healthcare? 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.

What will you be doing?

• 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

What will you need to be successful?

• 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

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve

Inclusion and Belonging

Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website.

Your Future

• 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement.

Work/Life Balance

• Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day.

Your Wellbeing

• Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program.

Flexibility

• Hybrid Work Model (for most professional roles).

Training

• Hands On, Team Customized, Mentorship.

Extra Perks

• Discounts on fitness clubs, travel and more!

Smith+Naphew 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.

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