QA Specialist II – QA Shop Floor (Fort Worth, TX)

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

The QA Specialist II – QA Shop Floor will 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.   He/she solves a range of problems in straightforward situations; analyzes possible solutions using technical/functional experience, judgment, and procedures.  Provides 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.

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.  He/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.

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

• Other responsibilities as identified by management.

Shifts:

Wed - Sun - 1st Shift

What will you need to be successful?

• Education:

  • Bachelor’s degree in science or engineering

• Experience:

  • 2-5 years relevant experience

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

  • Experience in manufacturing or quality assurance functions preferred.

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

  • Experience with equipment and processes validation is desirable.

• 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.

• High degree of attention to detail.

• Knowledge and the ability to understand the impact of cGMPs, US and International regulatory requirements

• Ability to work well with all levels of personnel throughout the facility.

• Capable of rapidly absorbing large amounts of information and technical data regarding equipment and processes and apply this knowledge to the manufacturing environment.

• Physical Demands:

  •  Chemical Exposure:  Occasional use of chemical may be required.

  • Physical Risk (Personal Protective Equipment – PPE):  Use of PPE will be required as per local procedures.

  • Must be able to walk/stand for long periods of time donned in cleanroom garments.

• Travel Requirements:  <10%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement