Quality Assurance Associate

Sanford, NC, USA
Career Opportunity  
Your Vision. Our Mission. For Patients. 

Abzena is proudly opening a brand new, state of the art manufacturing facility in Sanford, NC. We are seeking a Quality Assurance Associate to join our Quality Operations Team who will be responsible for ensuring the site performs in a state of compliance by leading Quality oversight activities while fostering an empowered culture of quality across all functions. This is an entry level position. 

As a new state of the art facility, you will be a pioneer of our organization. If you meet our qualifications, find joy in doing this type of work for partners and towards treatment for patients, and would like to be part of an inclusive, agile, and learning culture - we would like to hear from you! 

Responsibilities 
  • The Quality Assurance Associate will support quality functions in one of the following areas: Product Disposition, QA GMP Technical Services, Raw Materials and Laboratory Operations, and Manufacturing Quality Assurance.  Some general responsibilities area as follows: 
    • Product Disposition 
      • Support the disposition process of DP/DS/Intermediates 
      • Support activities to ensure timely disposition of DP/DS/Intermediates 
    • QA GMP Technical Services 
      • Operating within and supporting Quality Systems Operations 
      • Assist in generation of Quality Metrics 
      • Assist the Supply Chain team  
      • Assist root cause analysis and write up of minor deviations 
      • Assist as needed with Tech transfer activities 
    • Raw Materials and Laboratory Operations  
      • Provides QA review and support to QC and Warehouse 
      • QA responsibilities for Raw Materials sampling disposition and Qualification 
      • Raw Materials Specifications review  
      • Review protocols, reports, method SOPs, CoA for QC Operations 
    • Manufacturing Quality Assurance 
      • Imbedded in production 
      • Provide real time review of batch documentation 
      • Perform housekeeping checks  
      • Review of minor deviations, initiation of Major Deviations 
      • Quality representative in production 
      • Empowered to make quality decisions in real time in line with regulations and procedures 
      • Room and line clearances 
      • Support documentation creation and initiation 
Qualifications 

Mindset and Behaviors 
  • Exemplifies a growth mindset. 
  • Thrives in a start-up, agile work environment. 
  • Thrives in a diverse, inclusive, team-centric environment. 
  • Believes in shared accountability across functions and levels. 
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission. 
  • Applies lean concepts to improve the operations efficiency. 
  • Enjoys being involved with production and maintaining quality standards 
Must-Have 
  • Excellent communication, writing and analytical skills. 
  • Capable of working independently and with minimal supervision.   
  • Makes decisions pertinent to their area of responsibility. 
  • Ability to read, write, and understand complex situations. 
Nice-to-Have  
  • Bachelor’s degree in related field. 
  • Experience in Quality Assurance. 
  • Experience with Deviation Report, Change Control, and review experience. 
  • Member of professional affiliations such as PDA, ASQ.  
Work Schedule and Travel Requirement 

Regular business hours or shift schedule 

Physical/Mental Requirement 

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.  Capable of accessing the manufacturing areas as needed.  

Great Benefits: 
  • 100% Employer Paid Health, Dental, and Vision Benefits 
  • 100% Employer Paid Basic Life & AD&D, Short-Term Disability, Employee Assistance Program 
  • 5% 401k Employer Contribution through Fidelity 
  • 23 Days of Paid Time Off, increasing to 28 days after 5 years of employees 
  • Tuition Fee Reimbursement up to $5, 250 per year for degree, certification, development programs 
Abzena is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identify and expression, parental status, protected veteran status, disability/handicap status, national origin, age, disability, citizenship status, marital status or any other characteristics protected by applicable laws, regulations and ordinances.