American Society for Quality (ASQ), Asepsis, Biology, Biotech and Pharmaceutical, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Drug Manufacturing, Environmental Monitoring, FDA Requirements, Fitness, Identify Issues, Lean Six Sigma, Lift/Move 40 Pounds, LinkedIn, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Mentoring, Physical Demands, Problem Solving Skills, Process Improvement, Quality Assurance, Quality Control, Safety Compliance, Safety Standards, Six Sigma Certification, Standard Operating Procedures (SOP), Team Player, Time Management, Willing to Travel
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:
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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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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Smith & Nephew Plc
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.
Thomas James Smith black and white photograph
Image: Thomas James Smith
A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months.
By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments.
In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities.
Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange.
In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation.
Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.
2,000 to 2,499 employees
Medical Devices and Supplies