QA Shop Floor 2 - 2nd & 3rd Shift (Fort Worth, TX)

Smith & Nephew • Fort Worth, TX

2d • Onsite

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about quality and manufacturing excellence? Join our Fort Worth site as a QA Shop Floor 2 professional, where you will play a critical role in ensuring our products meet the highest standards of safety, compliance and quality. This is a hands-on, on-the-floor role for someone who thrives in fast paced manufacturing environments and enjoys partnering closely with operations to solve real time challenges. There are 2 available shifts for this role: 2nd Shift: Monday - Friday. Schedule: 3 pm - 11:30 pm. 3rd Shift: Monday - Friday. Schedule: 10 pm - 6:30 am.

Requirements

• Bachelor’s degree in science, engineering, life sciences or a related field
• 2 to 5 years of experience in quality assurance or manufacturing within pharmaceutical, biotech or medical device environments.
• Experience with aseptic filling, environmental monitoring, visual or functional inspection, or similar manufacturing processes
• Strong knowledge of cGMP, FDA regulations and quality systems
• Excellent attention to detail, communication skills and the ability to make independent quality decisions in real time
• Ability to work collaboratively with manufacturing personnel to solve issues

Nice To Haves

• Lean or Six Sigma certification preferred and ASQ desirable

Responsibilities

• Providing real time quality oversight and decision-making during manufacturing operations including fermentation, API manufacturing, aseptic filling and packaging
• Performing on the floor quality inspections, walkthroughs and GEMBA walks to ensure compliance with cGMP, procedures and specifications
• Conducting real time review of batch records, logbooks and production documentation to ensure ALCOA and Good Documentation Practices
• Identifying, documenting and escalating nonconformances, deviations and defects, while supporting timely investigations and closures
• Executing product containment, segregation, restrictions and batch disposition activities as required
• Collaborating closely with manufacturing teams to troubleshoot issues, drive continuous improvement and maintain audit readiness
• Supporting additional quality activities such as SOP updates, CAPA follow up and quality system improvements as needed

Benefits

• 401k Matching Program
• 401k Plus Program
• Discounted Stock Options
• Tuition Reimbursement
• Flexible Personal/Vacation Time Off
• Paid Holidays
• Flex Holidays
• Paid Community Service Day
• Medical, Dental, Vision
• 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, Mentorship
• Discounts on fitness clubs, travel and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees