Job Description

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

Join us in Fort Worth, TX as a QA Shop Floor 3 and become the primary quality presence on the manufacturing floor. This is an opportunity for someone who thrives in fast paced, highly collaborative environments and wants to directly influence product quality, compliance and operational excellence. If you enjoy solving problems in real time, guiding teams and ensuring every detail meets the highest regulatory standards, this role offers a rewarding challenge.

There are 3 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.
• 4th Shift (weekend): Saturday - Monday. 6 am - 6 pm.

What will you be doing?

• Acting as the on the floor quality lead, providing real time compliance oversight and support across manufacturing operations including fermentation, API manufacturing, aseptic filling and packaging
• Conducting walkthroughs to assess cleanroom behaviors, aseptic techniques and adherence to cGMP
• Performing real time documentation review of batch records, logbooks and production forms to ensure ALCOA principles and Good Documentation Practices
• Identifying and assessing non conformances, discrepancies and deviations, initiating deviation reports and supporting investigations and CAPA identification
• Executing product containment, restrictions and disposition activities for manufactured lots
• Performing quality inspections and AQL sampling to verify equipment, processes and products meet specifications and regulatory requirements
• Coaching and mentoring operators and junior QA team members on cleanroom behaviors, aseptic practices and GMP expectations
• Supporting SOP revisions, retain management and other quality tasks as required

What will you need to be successful?

Education:

• Bachelor’s degree in science, engineering, life sciences or a related field

Certifications:

• Lean or Six Sigma certification preferred and ASQ desirable

Experience:

• 5+ of relevant experience in pharmaceutical, biotech or medical device manufacturing or quality assurance
• Experience with aseptic filling, environmental monitoring or visual, physical or functional product inspection
  

Knowledge:

• Strong understanding of cGMP, FDA regulations and quality systems
• Proficiency with Microsoft Project or Excel, Word and PowerPoint

Competences:

• Ability to make real time quality decisions, identify issues and collaborate effectively with manufacturing
• High attention to detail and strong communication skills

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 (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, 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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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.

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