QA Specialist II – QA Shop Floor

5 months ago

Fort Worth, United States Smith+Nephew Full time

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.

Work Hours: 2nd 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:

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