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

The Quality Specialist 2 works within the Quality Operations group as a compliance SME for Fort Worth manufactured product and related sub-contractors. The Quality Specialist 2 is responsible for batch record reviews, commercial product release and most activities that have direct product impact including manufacturing, distribution, and storage of Intermediate, API, and Finished Product. They will also serve as a SME for approvals for various quality systems such as CAPA, Non-conformance, Change Control, external and internal audits/inspections.

What will you be doing?

• Performs product release of Fort Worth manufactured product including releasing product within the ERP LN, SAP inventory management and TraceLink systems as appropriate. Works within the quality management system and ensuring functional compliance to the applicable FDA cGMPs, GDP, (Smith+Nephew and outsource suppliers).

• Performs batch record review as needed for product release activities for Fort Worth site and related sub-contractors. Review and oversee warehouse incoming inspection documentation, NCs, Temperature data and Rework.

• Supports customers with issues related to Tracelink application EPCIS files.

• Reviews and approves SOPs, specifications, investigations, CAPAs, and change controls from Fort Worth and related subcontractors; provides feedback for needed changes and corrections.

• Performs creation of CofA and approval of laboratory documentation for product release and other lab testing.

• Reviews and releases documentation for incoming materials.

• Performs quarterly review of lab logbooks.

• Prepares and/or revises Standard Operating Procedures associated with product release/distribution and related activities. Ensures continuous improvement in all areas of QA release.

• Participates/Assists with internal and external audits/inspections.

• Other duties as defined by management

What will you need to be successful?

• Education:

  • B.S. in Chemistry, Biology, Microbiology or other science related field is preferred. Science field may be waived with appropriate experience.

  • Licenses/ Certifications: Relevant certifications preferred (ASQ, CQE, CQA)

• Experience:

  • Minimum 5+ years of experience in a quality assurance environment in a regulated industry

• Knowledge of cGMP, GDP, ICH, EU, MHRA and FDA guidance and regulations

• Team player with high energy level

• Ability to work outside of scheduled hours if needed. Good interpersonal skills, patience, persistence. Ability to convey a professional image to customers. Ability to work and prioritize independently.

• Strong computer, scientific, and organizational skills

• Strong communication (oral and written) and attention to detail.

• Ability to work with minimal supervision. Self-motivated, adaptable, and have a positive attitude.

• Ability to learn new techniques quickly, perform multiple tasks simultaneously, keep accurate records and comply with company policies.

• Physical Demands: Minor physical demands: Lifting boxes 10-25 lbs, reaching, and bending.

• 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.