QA Associate I/II

The Quality Assurance Raw Material Associate II is responsible for reviewing, inspecting, and evaluating all material receipts at Abzena to meet established Local procedure requirements. Ensure all Quality controls defined are met accordingly. Capable of escalating a potential deviation to avoid any potential deviation. Ensure to follow good documentation practice during execution. Promote a Quality mindset environment and ensure following the Health and Safety recommendation and guidance.

Responsibilities

• Capable of evaluating the materials receipt package in accordance with approved procedures.
• Executes real-time documentation during the material inspection process.
• Support in the sampling coordination to ensure material is inspected within the time needed.
• Ensures the inspection is executed according to approved specifications. Can execute transactions in the ERP system as required.
• Perform sampling and identification testing of incoming and release of raw materials.
• Works independently and with minimal supervision.
• Escalates/initiates/owns deviations.
• Can provide witness role for other staff’s execution during the material inspection process.
• Drafts/reviews/approves Standard Operating Procedures and supports the workflows in the electronic system.
• Identifies process improvements.
• Makes quality decisions in real-time according to regulations and procedures.
• Works in cross-functional teams to meet and exceed timelines.
• Facilitates all the documentation to support Material disposition after inspection.
• Provides excellent communication, writing, and analytical skills
• Operates to the highest ethical and moral standards.
• Complies with Abzena's policies and procedures.
• Communicates effectively with clients, supervisors, colleagues, and staff.
• Participates effectively as a team player in all aspects of Abzena's business.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
• Perform other duties as assigned.
• Thrives in an agile work environment and can be flexible when the business is needed.
• Provides support as QA review and support QC, Operation, and Warehouse when needed.

Qualifications

• Degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
• 2 to 5 years of experience in Quality Assurance and/or Raw Material inspection in GMP facilities or equivalent experience, Raw Material Quality Inspection preferably.
• Familiar with Pharmacopeia requirements. (i.e., USP, JP, EMEA)
• Knowledge of and experience in GMP environment, following applicable regulations.

FLSA: Exempt

Abzena is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.