QA Document Control Specialist

Life Unlimited. At Smith+Nephew 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!

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