Associate II, Quality Assurance

Job Summary:

The Associate II, QA – Product Disposition will be responsible for ensuring the site performs in a state of compliance by leading and supporting all Quality oversight activities related to product disposition of Drug Substance, Intermediates, Drug Product, meeting all applicable regulatory requirements and Abzena standards.  This will be accomplished by fostering an empowered culture of quality across all functions.  The Senior Quality Assurance Associate-Product Disposition will additionally provide Quality Systems support, as required.

Responsibilities

• The Associate II, QA Associate Product Disposition is a regular Business Hours role that will support the Product Disposition quality function.

• Works closely with colleagues through all phases of drug process to ensure compliance and timeliness of GMP work.
• Manages and oversees the disposition process of DS/DP/Intermediates.
• Organizes activities to ensure timely disposition of DP/DS/Intermediates.
• Maintains consistent communication with programs/project managers to understand customer needs and timelines.
• Participates in client and regulatory inspections.
• Identifies and executes efficiency projects for the area.
• Authors/reviews SOPs, deviations, CAPAs, and change controls.
• Performs final disposition of finished product for clinical/commercial use, ensuring country-specific disposition requirements are met.
• Assists with executing and maintaining Electronic Management Systems as it relates to product disposition, i.e., ERP.
• Participates effectively as a team player in all aspects of Abzena’s business.
• Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Provides communication in both verbal and written formats.
• Prioritizes and manages workload for multiple projects and tasks simultaneously to successfully meet goals and objectives.
•  Operates in both a team and individual setting with minimal supervision.

• Makes decisions pertinent to their area of responsibility.
• Exercises higher level judgment and assessment skills for more than 75% of the assigned workload.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
• Operates to the highest ethical and moral standards.
• Complies with Abzena’s policies and procedures.
• Communicates effectively with clients, supervisors, colleagues, and staff.
• Participate effectively as a team player in all aspects of Abzena’s business.
• Perform other duties as assigned.

Requirements:

• Minimum of B.S. degree in Life Sciences or related discipline with ≥ 3 years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
• Relevant experience in product quality activities similar or related to product disposition, shop floor QA, incoming quality.

• 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.
• Proven ability to complete all work with detailed accuracy.
• Proven ability to work in a fast-paced environment to meet tight deadlines.
• Proven ability to serve as an active participant and contributor in cross-functional meetings.
• A proven ability to analyze, assess, and resolve issues as they arise.

Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.  

Physical Requirements:

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Frequently lift and or move objects up to 30 pounds.
• Stand/walk during entire length of shift.
• Use arms, hands, and fingers to handle, feel or reach.
• Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.

• Ability to gown and gain access to cleanroom and utility areas.

FLSA: Non-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.