Smith+Nephew
Smith+Nephew
Posted 3 months ago
Full Time
Fort Worth, Texas
In Person
Smart Summary
Responsibilities
The role involves providing real-time quality oversight during manufacturing operations, including fermentation, API manufacturing, and aseptic filling. You will also perform floor inspections, review batch records for compliance, and collaborate with teams to resolve quality issues.
Qualifications
We are looking for a QA Shop Floor professional with a Bachelor's degree in science, engineering, or a related field. You should have 1-2 years of experience in pharmaceutical, biotech, or medical device manufacturing or quality roles, and a working knowledge of cGMP and FDA regulations is expected. Strong attention to detail and communication skills are essential for this role.
Job Description
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.
Work Schedule: This is a 4th Shift weekend role, scheduled for Saturday to Monday, 6:00 a.m. to 6:00 p.m.
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:
Experience:
Knowledge:
Competences:
You Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
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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