Quality Control Associate I or II

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 QC Associate I or II to join our Quality Control Team who will be responsible for routine testing of incoming raw materials and product (e.g. in-process, release, stability, etc.) in support of GMP manufacturing at Abzena.  Focus areas include execution of analytical method qualification/validation protocols, routine analytical testing and documentation/data review of QC generated results.  The position prefers experience within a QC setting and 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
  • 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, CE, fluorescence assays, particle sizing, bioburden, and endotoxin, etc.) 
  • Executes qualification/validation protocols and writes technically sound qualification/validation reports.
  • Participates in method and equipment qualification and validation in the QC laboratory.
  • Provides review of QC data and associated documentation.
  • Supports 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 prep, forms control, etc.).
  • Train on all relevant procedures, as appropriate.
  • Performs other related duties as assigned.
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. 
  • Flexibility with changing priorities.
  • 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.
  • Working knowledge of compendia testing (USP, Ph. EUR, JP, etc.) wet chemistry techniques and analytical analysis (U/HPLC, GC, FTIR, KF, etc.).
  • Support implementation of programs (e.g. evaluation/implementation of compendial testing).
  • Contributes to Quality Control department goals and objectives.

Must-Have
  • B.S. in applicable science field 
  • 0-5 years of experience in an GMP Laboratory setting.
  • 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 preparing analytical test reports, qualification/validation protocols, qualification/validation reports and SOPs. 
  • Familiarity with compendia (USP, Ph. EUR, and JP) and ICH guidelines.
  • Strong written and oral communication skills, proficiency with Microsoft Office software.

Nice to Have
  • Experience with the transfer and qualification/validation of large molecule focused analytical methods is a plus.
  • Data Trending and control chart interpretation is desirable.

Work Schedule and Travel Requirement
Ability to travel between Abzena sites (Bristol PA, San Diego CA, and Sanford NC) 

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.


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.