Quality Assurance Raw Materials Associate - Abzena

Quality Assurance Raw Materials Associate

Location:
Area:

Typical Duties Include

  • Performs inspection and labeling of released raw materials.
  • Prepares appropriate documentation for acceptable vendor materials.
  • Reviews and dispositions raw materials.
  • Reviews completed analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Reviews, edits, and approves specifications and SOPs.
  • Performs certificate of analysis reviews.
  • Performs testing on incoming materials.
  • Performs hands-on monitoring of outgoing product shipments, cell vial transfers and disposals.
  • Performs inspections of returned materials for continued use in manufacturing.
  • Initiates, reviews and approves non-conforming material reports.
  • Has overall responsibility for the non-conforming materials program.
  • Requires lifting up to 50 pounds.
  • Approximately 50% of time will be spent performing activities in a warehouse environment.

 

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 and colleagues.
  • Ability to participate effectively as a team player in all aspects of Abzena’s business.
  • Travels as needed to attend professional conferences and to train on new technologies.

 

Qualifications/Skills Required:

  • Specialist level – Requires BS/BA in scientific discipline or related field and minimum 5 years of relevant experience. Relevant experience may be substituted for education requirement.
  • Good organizational skills and attention to detail.
  • Knowledge of cGMP, 21CFR, USP, and other applicable regulations, standards, and guidance.
  • Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
  • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact with all levels.
  • Ability to handle multiple assignments and changing priorities.
  • Solid computer skills and abilities.
  • Positive, proactive approach to drive assignments/tasks to completion.
  • Ability to stand for periods of time in a warehouse environment.
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