Quality Assurance Raw Materials Associate
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.
- 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.
- 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.