Sr QA Technical Writer

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 for 2 Quality Assurance Technical Writers to join our Quality Operations Team who will be responsible for the preparation, revision, and approval of quality records.  The technical writer also provides support leading root cause analysis and owning critical investigations. 

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 
  • Develop comprehensive documentation that meets organizational standards 
  • Write SOPs for Quality and other documents such as risk assessments, summary reports and presentations 
  • Provide guidance to other departments on technical writing  
  • Provides QA approval for records and reports 
  • If needed, to own critical investigations and leads root cause analysis 
  • Conducting interviews with SME’s and translating into digestible text and format 
Qualifications 

Mindset and Behaviors 
  • Exemplifies a growth mindset. 
  • Thrives in a start-up, agile work environment. 
  • Thrives in a diverse, inclusive, team-centric environment. 
  • Passionate about learning and open to feedback.  
  • Believes in shared accountability across functions and levels. 
  • Described as curious, organized, resourceful, and thoughtful. 
  • Operates to the highest ethical and moral standards. 
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission. 
Must-Have  
  • Bachelor's degree in relevant technical field such as life science, pharmacy, or engineering 
  • 2-4 years’ industry experience in similar roles 
  • 3 years relevant experience in quality, regulatory affairs or clinical research development 
  • Superior written and verbal communication skills, with a keen eye for detail 
  • Ability to make the complex simple to understand 
  • Ability to write objectively clear and concise material that shows no bias 
  • Good organization skills 
Nice -to-Have  
  • Proven ability to handle multiple projects simultaneously, with an eye for prioritization 

Work Schedule and Travel Requirement 

Regular business hours  

Physical/Mental Requirement 

Require working in an office setting where sitting and computer usage would be the norm. 

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.