4th shift (Fort Worth, TX)

Smith+Nephew•Fort Worth, TX

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in science, engineering, life sciences or a related field
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
Strong understanding of cGMP, FDA regulations and quality systems
Proficiency with Microsoft Project or Excel, Word and PowerPoint
Ability to make real time quality decisions, identify issues and collaborate effectively with manufacturing
High attention to detail and strong communication skills

Nice To Haves

Lean or Six Sigma certification preferred and ASQ desirable

Responsibilities

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