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

The QA Specialist I - 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. Interacts cross functionally with other functions including Supply Chain, Manufacturing, Quality Control, and other quality assurance functions.

What will you be doing?

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

• Responsible for providing quality oversight of manufacturing operations. 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/deviations 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 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.

• 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.

• Management of the manufactured product reserve program

Shift Based Roles:

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

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 process 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 thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about on our website ( ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

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.