Senior Quality Specialist - QA Shopfloor (Fort Worth, TX)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Senior QA Specialist – QA Shop Floor will perform the followings:

• Provide quality oversight of manufacturing operations by ensuring manufacturing operations are performed under a state of GMP compliance and in accordance to the requirements of the Smith and Nephew Quality System and Good Manufacturing Practices.

• Perform real time on-the-floor batch record review of manufacturing and packaging batch records, forms, and logbooks.

• Provide on-the-floor quality support and resolution guidance during manufacturing operations to include fermentation, API manufacturing, filling and packaging operations. Solve a range of problems in straightforward situations; analyses possible solutions using technical/functional experience, judgment, and procedures. 

• Represent the voice of QA Shop Floor on projects that will be implemented on the shop floor, as well as ensure appropriate training of QA Operations personnel prior to the deployment of the projects.

• Maintain the product reserve/retain program ensuring that product is properly obtained, documented, and stored at the appropriate conditions.  Also ensure that annual inspections assigned of the product are performed in a timely manner.

• Perform data analysis, track and trend data, identify corrective/preventive actions, and identify/implement process improvements to advance the quality and compliance of the quality and manufacturing processes.

• Provide quality oversight of operations through the quality approval of manufacturing procedures, batch records, and forms and quality sign off for process equipment/utilities calibration and preventative maintenance activities.   

• Provide guidance to new and/or junior team members.  Interacts cross functionally with other functions including Supply Chain, Manufacturing, Quality Control, and other quality assurance functions.

• Release product for specific manufacturing phases (PBS and sterilization API processes) and QC support processes (tweezed collagen). 

What will you be doing?

• Providing quality oversight of manufacturing operations. Review in-process documentation supporting the manufacture of intermediates, API, and products, as well as facility and equipment usage and cleaning. 

• Provide quality input and decision making for quality and manufacturing issues as they arise on the shop floor.  She will provide support to manufacturing in the investigation of non-conformances and will provide input related to product quality impact from such events and will provide guidance and assistance with product containment and/or segregation of non-conforming material.

• Provide quality inspections on the floor, AQL sampling/inspection of in-process intermediates and finished products and performing quality checks to ensure equipment and processes are in compliance to procedures, specifications, and cGMP requirements.

• Provide quality approval of manufacturing procedures, batch records, and forms and quality sign off for process equipment/utilities calibration and preventative maintenance activities.  He/she will support the QA Validation function by providing review and approval of validation protocols and/or reports for the validation of manufacturing equipment and processes. He/she will represent the voice of QA Shop Floor on projects that will be implemented on the shop floor, as well as ensure training of QA Operations personnel prior to the deployment of the projects.

• Release of product for specific manufacturing phases (PBS and sterilization API processes) and QC support processes (tweezed collagen).

• Other responsibilities as identified by management.

What will you need to be successful?

• Education:

  • Bachelor’s degree in science or engineering preferred

• Experience:

  • 2-5 years relevant experience

  • Experience in the pharmaceutical/biotech/medical device industry required. 

  • Experience in manufacturing or quality assurance functions required.

  • Experience working in aseptic filling operations, media fills, and in clean room environments is preferred. 

  • Experience with equipment and process validation is preferred.

• Must have effective written/oral, interpersonal, organizational skills.

• Strong analytical skills, problem solving techniques and technical skills.

• Must be able to provide and implement solutions to quality problems.

• Possess a high degree of attention to detail.

• Knowledge and