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

Smith+Nephew•Fort Worth, TX

3d•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. 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! #LI-ONSITE #LI-CA1 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. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

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
Ability to walk, stand, lift (up to 40 lbs), climb ladders/stairs, and work in high noise spaces.

Nice To Haves

Lean or Six Sigma certification preferred
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