Associate, Quality Operations

Genezen•Indianapolis, IN

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. PURPOSE Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

Requirements

Bachelor’s degree in science or related field Essential
Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials Essential
Familiarity of eQMS systems such as Veeva Desired
3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role Essential
Experience working in with early phase clinical trial production and testing Desired
Manage multiple projects, set priorities, and work in fast-paced environment Essential
Communicate confidently and effectively with management, peers and key stakeholders Essential
Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving Essential
Work independently and be self-motivated Essential
Proven ability to work cross-functionally to achieve business outcomes Essential

Nice To Haves

Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms
Experience working in with early phase clinical trial production and testing
Previous experience with a startup CDMO and/or in the field of Gene Therapy

Responsibilities

Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence.
Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
Review, assess, and release quality control tests and Certificates of Analysis
Review and approve executed batch records.
Provide guidance and support to departments on errors to ensure error reduction.
Assist in the final disposition of master cell banks and viral vector products.
Review and approve qualification/validation protocols and reports and technology transfer reports.
Provides site GMP and GDP training (annually, for new-hires, and as needed).
Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
Drive Quality Events to closure within on-time closure deadlines.
Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
Review and approve Master Batch Records.
Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
Review and approve Stability Protocols.
Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
Initiate, review, approve and monitor Change Management activities
Work with the other functional areas to give guidance on use of quality systems.
Assist the Lead Auditors to perform site internal audits.
Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations
Adaptability required as work schedule may change based on business needs
Criminal background check and drug screen required
Other duties as assigned