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

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.

What will you be doing?

• 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

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:

• 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

Knowledge:

• Strong knowledge of cGMP, FDA regulations and quality systems

Competences:

• 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.

Physical Demands: While performing the duties of this position, the Employee will be required to walk, stand, lift (up to 40 lbs), climb ladders/stairs, and work in high noise spaces.

Travel Requirements: Up to 10% (international and domestic)

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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