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
