QA Specialist II

Role Overview:

Responsible for providing quality oversight of manufacturing operations. He/she will ensure manufacturing and support operations are performed in compliance with regulatory expectations, Smith and Nephew Quality System requirements, and current Good Manufacturing Practices.

Shift Based Roles:

1st Shift - Monday-Friday 7:00 AM - 4:00 PM; Wednesday - Sunday - 7:00 AM - 4:00 PM

2nd Shift - Monday-Friday 3:00 PM - 12:00 AM; Wednesday - Sunday - 3:00 PM - 12:00 AM

Responsibilities:

• Provide quality oversight of manufacturing operations. Ensure manufacturing operations are operating under a state of compliance and in accordance to the requirements of the Smith and Nephew Quality System and Good Manufacturing Practices.
• Provide on the floor quality support during manufacturing operations to include fermentation, API manufacturing, filling and packaging operations.
• Provide quality inspections on the floor, AQL sampling/inspection of in-process intermediates and finished products, and performance of 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. 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 and QC support processes.
• Provide quality input and decision making for quality and manufacturing issues as they arise on the shop floor and initiate product restrictions; Pursue resolution of these issues as they arise and issue product restrictions as required. Provide input related to product quality impact from such events and provide guidance and assistance with product containment and/or segregation of non-conforming product/material. Support the timely investigation, mitigation, approval, and closure of non-conformances.
• Perform real time on-the-floor batch record review of manufacturing and packaging batch records, forms, and logbooks. He/she will provide guidance to manufacturing to resolve errors and deficiencies identified during the batch record review activities. The QA Specialist may perform additional tasks in support of the manufacturing function.
• Maintain the product reserve/retain program ensuring that samples are properly obtained, documented, and stored at the appropriate conditions. Ensure that annual inspections of the product are performed in a timely manner.
• Perform data analysis, identify corrective/preventive actions, and identify/implement process improvements to advance the quality and compliance of the quality and manufacturing processes.
• 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.
• Other responsibilities as identified by management

Location:

• US - Fort Worth, TX

Education:

• Bachelor's degree in science or engineering

Experience:

• 2-5 years' relevant experience in the pharmaceutical/biotech/medical device industry required
• 2-5 years' experience in manufacturing or quality assurance functions preferred.
• 2-5 years' experience working in aseptic filling operations, media fills, and in clean room environments is preferred.
• Experience with equipment and processes validation is desirable.

Competencies:

• 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 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 applying 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 to walk/stand for long periods of time

Travel:

< 10%

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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.