Associate, Quality Operations

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.

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

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

Desired

ON-THE-JOB EXPERIENCE

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

Previous experience with a startup CDMO and/or in the field of Gene Therapy

Desired

SKILLS / ABILITIES

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

• 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

• C ommitted to Science
• We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

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

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

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

• S olutions 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

Paid sick time

10 observed holidays + 2 floating holiday + 1 volunteer day

401(k) plan with company match up to 6% of salary

Share Appreciation Rights

Choice of several healthcare plans

FSA and HSA programs

Dental & vision care

Employer-paid basic term life/personal accident insurance

Voluntary disability, universal life/personal accident insurance

Accidental Death & Dismemberment (AD&D) 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.

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