QA Shop Floor 1 - Weekend Shift (Fort Worth, TX)

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

Join our Fort Worth manufacturing site as a QA Shop Floor 1 professional and be part of a team that plays a vital role in protecting patient safety and product quality. This is an on the floor quality role where you will partner closely with manufacturing to support compliant operations, resolve issues in real time and build a strong culture of quality.

What will you be doing?

• Providing real time quality oversight during manufacturing operations including fermentation, API manufacturing, aseptic filling and packaging

• Performing on the floor quality inspections, walkthroughs and AQL sampling to ensure compliance with cGMP and internal procedures

• Reviewing batch records, logbooks and production documentation in real time to ensure ALCOA and Good Documentation Practices

• Identifying and documenting nonconformances, deviations and defects, and supporting timely investigations and resolution

• Supporting product containment, segregation, restrictions and batch disposition activities as needed

• Collaborating with manufacturing teams to resolve issues, maintain data integrity and support audit readiness

• Assisting with additional quality activities such as SOP updates, CAPA follow up and quality system support

What will you need to be successful?
 

Education:

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

Experience:

• 1 to 2 years of experience in pharmaceutical, biotech or medical device manufacturing or quality roles is required
• Experience with aseptic filling, environmental monitoring or visual, physical or functional product inspection is strongly preferred.
   

Knowledge:

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

Competences:

• Strong attention to detail with the ability to document and communicate quality issues clearly
• High attention to detail and strong communication skills
• Ability to work collaboratively with manufacturing personnel to solve issues

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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