Sr. Associate, Quality Operations

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.

ESSENTIAL JOB FUNCTIONS / DUTIES

• 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
• Ensure that all products manufactured at the site are produced, tested and released in compliance with SOP’s, cGMP’s, FDA and EU requirements
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve Master Batch Records (MBR’s) and 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
• Provides site GMP and GDP training (annually, for new hires, and as needed)
• Initiate and perform Root Cause Analysis for Quality Events such as minor and major 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
• Generate, review and approve Media Fill Protocols and summary reports, as well as participate as a Quality observer as needed
• Perform and assist with Quality Oversight for Manufacturing, QC and warehouse
• 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
• Lead and perform site internal audits
• Lead and/or support customer audits, audit readiness 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

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired 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 Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms Desired Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms Desired ON-THE-JOB EXPERIENCE 6+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role Essential Leadership or Mentoring Responsibilities Desired Experience working in with early phase clinical trial production and testing Desired Previous experience with a startup CDMO and/or in the field of Gene Therapy Desired SKILLS / ABILITIES Essential Manage multiple projects, set priorities, and work in fast-paced, ever-changing environment Communicate confidently and effectively with management, peers and key stakeholders Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving Work independently and be self-motivated Proven ability to work cross-functionally to achieve business outcomes

PHYSICAL DEMANDS

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time
• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
• Frequent utilization of close vision and the ability to adjust focus
• 20/20 or Corrected 20/20 Vision
• Frequent communication by talking, hearing, using telephone and e-mail

WORK ENVIRONMENT

Regularly sit for long periods of time

ADDITIONAL DETAILS

• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
• Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
• Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
• Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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