Sr. QA Associate

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Typical Duties Include

  • Support manufacturing operations on the production floor as well as batch release functions.
  • Perform review of production batch records and test records for buffers, master cell banks, intermediates, and drug substance.
  • Perform review of all GMP record types related to production, metrology, facility, and equipment.
  • Initiate and participate in the investigations into environmental monitoring excursions to assess any potential impact to product.
  • Perform line/room clearances and support manufacturing needs on the floor.
  • Provide support in disposition of raw material used in cGMP manufacturing.
  • Analyze data and documentation to support recommendation for batch disposition.
  • Comply with SOPs and procedures to work in cGMP environment.
  • Review and revise SOPs, specifications, and reports.
  • Initiate and participate in investigations for manufacturing deviations.


General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
  • Communicates effectively with supervisors, colleagues, customers, and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed to attend professional conferences, and train on new technologies.


Qualifications/Skills Required:

  • BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)
  • Minimum Three (3) years of GMP Quality Assurance experience, preferably in a contract manufacturing organization.
  • Knowledge of cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
  • Ability to deploy quality systems within the biologics industry.
  • Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
  • Skill in writing to effectively communicate complex ideas and concepts.
  • Knowledge of contract manufacturing processes and relevant quality assurance programs.
  • Knowledge of cGMP auditing practices.
  • Ability to work well under pressure, multi-task, be organized, and communicate effectively.
  • Ability to meet gowning requirements to be able to work on manufacturing floor.
  • Skill to read, write, and modify documents, to include Standard Operating Procedures (SOPs).
  • Ability to review and understand test data.


FLSA:  non- Exempt

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