Quality Assurance Associate II (Columbia, MD)

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

The QA Associate II is responsible for reviewing production control records and all associated documentation for manufactured tissue products.

What will you be doing?

• Review of supplemental documentation associated with tissue product production performed, including label records, environmental monitoring records, autoclave records, cleaning records, quality control testing records, autoclave records, and donor eligibility records.

• Review and evaluation of tissue product production records for disposition.

• Maintenance and reporting of the production record review metrics.

• Scanning, filing, and archival of QA related documents.

What will you need to be successful?

• Education: Minimum of a bachelor's degree in Life Sciences or science based field

• Experience: At least 2 years of experience in a regulated biotechnology or pharmaceutical environment in a quality role

  • 1 - 2 years of experience performing batch record review or manufacturing using batch records at a regulated biotechnology or pharmaceutical company

  • 1 - 2 years in Quality performing batch record review and disposition of products at a regulated biotechnology or pharmaceutical company preferred

• Understanding of Good Tissue Practices (GTP) or Good Manufacturing Processes (GMP) and Quality Systems.

• Knowledge of Microsoft Office applications.

• Ability to work independently.

• Ability to work with cross-functional teams to facilitate progress and meet timelines and metrics.

• Ability to pay continuous attention to detail, including documentation of procedural details when performing repetitive critical tasks.

• Excellent interpersonal and communication skills inside and outside of the department.

• Physical Demands: Office area, warehouse area, controlled temperature storage areas, be able to lift at least 50 lbs.

• Travel Requirements: 0-5%

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  
  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.

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