Sr QA Associate, Operations

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 Sr. Associate, Quality Operations will ensure the site performs in a state of compliance by supporting Quality oversight activities and fostering an empowered culture of quality across different functions.  The Associate will perform batch record review of buffer/media/process records, support approval and management of Deviations/ Change Controls / CAPAs and support on the floor activities as needed.

Responsibilities

• Provide hands-on QA collaboration, ensuring compliance to good documentation practices, data integrity compliance, site inspection readiness SOPs, and relevant Good Regulated Practice (GxP) requirements.
• Author minor and major deviations and perform a thorough investigation to drive remediation efforts.
• Facilitate investigations and support deviation owners as needed using root cause analysis tools as needed.
• Provide Instructor Lead Training to the site on deviations, CAPAs and change controls
• Review and Approve manufacturing deviations (minor), CAPAs, change controls and Standard Operating Procedures (SOPs).
• Perform batch record review for buffer / media, upstream and downstream manufacturing batch records.
• Author Standard Operating Procedures (SOPs) for topics that pertain to Quality Assurance Operations.
• Work on the floor during production and help make quality decisions to ensure compliance with procedures and regulations as needed.
• Collaborate cross site on key quality topics.
• Perform regular area walkthroughs of the manufacturing and Quality Control areas.
• Support client and internal audits.
• Support other departments as required to fulfill business needs.
• Comply with Abzena's policies and procedures.
• Communicate effectively with supervisors and colleagues.
• Participate effectively as a team player in all aspects of Abzena's business.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. 

Qualifications

• Minimum of B.S. degree in Life Sciences or Engineering with ≥ 5 years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
• 5 -10 years of experience in a Quality Assurance-related function.
• Experience overseeing manufacturing operations, batch record review, quality records and disposition.
• Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial.
• Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
• Ability to work in a cross-functional environment and resilience to a fast-paced environment.

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.