Associate, Quality Operations

Genezen; Indianapolis (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Health insurance

FSA/HSA programs

Job summary

Genezen is seeking a Quality Assurance professional to provide oversight over Manufacturing, Quality Control, and related areas to ensure GMP compliance and adherence to company policies. The role includes guiding production staff, reviewing batch records, and developing SOPs within a fast-growing gene therapy CDMO.

Ideal candidates have 3–5 years in pharmaceutical/biologics QA, familiarity with cGxPs and eQMS such as Veeva, and experience with early phase clinical trials.

Qualifications

• Bachelor’s degree in science or related field.
• 3-5 years of working experience in a Pharmaceutical or Biologics Quality Assurance role.
• Experience working in early phase clinical trials.
• Familiarity with eQMS systems such as Veeva.
• Knowledge of cGxPs, clean room controls, aseptic processing, and EMA/ISO standards.

Responsibilities

• Oversee QA of Manufacturing, Quality Control, and other areas on the floor ensuring GMP/SOP/compliance.
• Guide production staff on SOPs, GMPs and process improvements.
• Review batch records and logbooks for accuracy and contemporaneous completion.
• Ensure Genezen documentation complies with cGMPs, GDPs, and company policies.
• Develop and optimize SOPs and other QA controlled documents.
• Review and approve SOPs and documents for functional areas as QA representative.
• Review, approve and release materials for use in production and QC tests.
• Review quality control tests and Certificates of Analysis.
• Approve executed batch records and guide departments on error reduction.
• Assist in final disposition of master cell banks and viral vector products.
• Review and approve qualification/validation protocols and reports and technology transfer reports.
• Provide site GMP and GDP training (annual and as needed).
• Initiate Root Cause Analysis for Quality Events and drive closure.
• Collaborate cross-functionally to ensure product manufactured per approved procedures.
• Assist Lead Auditors with internal audits and participate in external audits/reg inspections.

Skills

Quality Assurance

GMP Compliance

SOP Development

CAPA Management

Root Cause Analysis

Cross-functional Collaboration

Training

Documentation Review

Education

Bachelor’s degree in science or related field

Job description

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

Manypeople 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
• 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

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

Bachelor’s degree in science or related field

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

Familiarity of eQMS systems such as Veeva

Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms

ON-THE-JOB EXPERIENCE

3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role

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

SKILLS / ABILITIES

Manage multiple projects, set priorities, and work in fast-paced 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

While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• 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

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

• Paid vacation days, amount based on tenure
• 401(k) plan with company match up to 6% of salary
• Choice of several healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

ADDITIONAL DETAILS

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• 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.