QA Label 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 schedulesAssign product lot numbers and perform inspection of batch records associated with manufacturing processesGenerate, review, and inspect complex product labeling, identifying even minor defects on printed labelsPrepare printing and inspection documentation in accordance with established procedures and good documentation practicesCoordinate printing activities to ensure manufacturing operations have the records and labels needed to maintain production flowSupport compliance with 21 CFR 1271 requirements and current American Association of Tissue Banks standardsScan, file, archive, and maintain quality records and controlled inventory documentationPrepare, verify, and manage quality records for off site storageWhat will you need to be successful?Associate's or Bachelor's degree, preferably in a science related fieldMinimum 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 consistentlyExperience in document control, label printing, label inspection, or other detail focused quality inspection activities preferredAbility to work independently in a fast paced environment while managing changing prioritiesStrong communication, decision making, and problem solving skillsWorking knowledge of quality systems and manufacturing or tissue practice standardsAbility to sit for extended periods, perform visual inspections, and lift boxes weighing up to 40 poundsYou. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serveInclusion 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!Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.Join a team where your engineering expertise will directly impact manufacturing excellence, product quality, and patient outcomes. As a Process Engineer 3, you will play a key role in driving continuous improvement initiatives, supporting new product introductions, and ensuring manufacturing processes and equipment meet the highest standards of compliance and performance.What will you be doing?Lead the development and implementation of manufacturing process improvements, production controls, and efficiency initiativesDrive risk assessments and gap assessments to strengthen current and future manufacturing processesOversee equipment and manufacturing process qualifications to support regulatory and operational requirementsAuthor, execute, and review change controls, validation protocols, CAPAs, and other quality system documentationSupport new product transfers from development into manufacturing and help ensure successful commercializationQualify new manufacturing equipment and support validation activitiesPartner with cross functional teams to identify and deliver cost saving and business transformation opportunitiesDevelop user needs documentation and contribute to solution driven manufacturing improvementsConduct research and development activities to evaluate the feasibility of new ideas and technologiesProvide technical support and leadership across manufacturing operations as neededWhat will you need to be successful?Bachelor's degree in Engineering or Life Sciences3+ years of manufacturing or process engineering experience within an FDA regulated environmentProficient in MS Office software (Word, Excel, PowerPoint)Demonstrated ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.Effective verbal and written communication skills.Open collaborative style; ability to work both in a team environment and autonomously with minimal supervision or directionUnfazed by ambiguity and comfortable in environments with shifting prioritiesStrong verbal and written communication skills, including solid interpersonal skillsProven time management and organizational skillsProven ability to build relationships across organizational departments and reporting structures.Travel Requirements: 0-5% 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!The anticipated base compensation range for this position is $22.83 - $34.25 USD hourly. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.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.Stay connected by joining our Talent Community.We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our website and learn more about our mission, our team, and the opportunities we offer. SummaryLocation: US - Columbia MDType: Full time