Quality Control Senior Associate

Sanford, NC, USA
Career Opportunity Summary  
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 Senior Quality Control Associate to join our Quality Control Team who will be responsible for performing multiple tasks within the Quality Control (QC) group in support of GMP large-molecule manufacturing activities.  

Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results.  The position requires extensive experience within a QC setting and detailed knowledge of GMP/GDP.    

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 
  • Provides critical QC centric review of draft Analytical Test Methods (ATMs) and qualification/validation protocols received from the Analytical Method Development (AMD) group.
  • Leads the execution of qualification/validation protocols and writes technically sound qualification/validation reports.
  • Leads the implementation of programs (e.g. evaluation/implementation of compendial testing).
  • Working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.).
  • Performance of QC raw material, in-process, and bulk drug product testing, as well as support of testing/review of data with/from contract testing laboratories (e.g. compendial methods, HPLC, fluorescence assays, particle sizing, bioburden, and endotoxin, etc.)
  • Provides expert review of QC data and associated documentation.
  • Leads laboratory investigations to determine root cause for OOS, OOT, Atypical  and invalid test results.
  • Contributes to laboratory operations by performing regular instrument calibration and minor instrument maintenance.
  • Support operational systems (e.g. equipment maintenance, reagent preparation, forms control, etc.).
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 Qualifications 
  • B.S. in applicable science field
  • A minimum of 5-7 years of relevant Quality Control industry experience in a GMP laboratory setting.
  • In-depth knowledge of the theoretical and practical aspects of analytical methods utilized to characterize large molecule therapeutics including: U/HPLC, CE, cIEF, ELISA, SDS PAGE and all compendial testing
  • Experience with the transfer and qualification/validation of large molecule focused analytical methods.
  • Experience with authoring, reviewing and approving analytical test reports, qualification/validation protocols, qualification/validation reports and SOPs.
  • Knowledge of compendia (USP, Ph. EUR, and JP) and ICH guidelines.
  • Strong written and oral communication skills, proficient with Microsoft Office software.
  • Data Trending and control chart interpretation.
Work Schedule and Travel Requirement
Ability to travel between Abzena sites (Bristol PA, San Diego CA, and Sanford NC) 

Physical Requirements   
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
 
While performing the duties of this job, the employee is regularly required to frequently lift and or move objects up to 20 pounds. Must have the ability to stand/walk during entire length of shift. Use of arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities include close, distance, color, peripheral, depth and ability to focus. 
  
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.