Sr. Associate, Quality Operations

Genezenlabs; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match

Choice of several healthcare plans

Dental & vision care

Job summary

Genezenlabs is seeking a Quality Assurance professional in Indianapolis to provide oversight and expertise in manufacturing and quality control activities. Key responsibilities include ensuring compliance with cGMP, approving essential documents, and driving quality processes.

The ideal candidate will have over 6 years of experience in a relevant field, a Bachelor’s degree in science, and strong communication skills. Genezen offers a comprehensive benefits package including paid time off, healthcare plans, and 401(k) matching.

Qualifications

• 6+ years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role.
• Experience with early phase clinical trial production.
• Familiarity with clean room controls and aseptic processing.

Responsibilities

• Provide quality oversight during manufacturing and quality control activities.
• Review and approve controlled documents and batch records.
• Conduct training on GMP and GDP.
• Initiate and perform Root Cause Analysis for Quality Events.

Skills

Project management

Effective communication

Problem-solving

Decision-making

Mentoring

Education

Bachelor’s degree in science or related field

Knowledge of GMP regulations

Tools

eQMS systems (e.g., Veeva)

Job description

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.
• Ensure that all products manufactured at the site are produced, tested and released in compliance with SOPs, cGMPs, FDA and EU requirements.
• Review, assess, and release quality control tests and Certificates of Analysis.
• Review and approve Master Batch Records (MBRs) 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:
  • 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:
  • Manage multiple projects, set priorities, and work in fast‑paced, ever‑changing 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
• 20/20 or Corrected 20/20 Vision

Communication

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

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.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.