Quality Operations Specialist — Gene Therapy

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

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.