What are the responsibilities and job description for the Sr QA Associate, Raw Materials position at Abzena?
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Quality Assurance Raw Material Associate 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. Disposition of Raw Materials received into inventory.
Responsibilities
- Capable of evaluating the materials receipt package in accordance with approved procedures.
- Executes real-time documentation during the material inspection process.
- Manages 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.
- Works independently and with minimal supervision.
- Owns deviations.
- Provides 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 and implements process improvements.
- Makes quality decisions in real-time according to regulations and procedures.
- Works in cross-functional teams to meet and exceed timelines.
- Executes and / or reviews Incoming suite area clearance.
- 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 a start-up, 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
80,000 - $90,000 a year
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.
Salary : $80,000 - $90,000
