Overview
Quality Operations Associate Jobs in Indianapolis, Indiana, USA at Harba Solutions Inc.
This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$23.00/hr – $25.00/hr
Guide production teams to ensure adherence to SOPs, GMPs, and process improvements.
Verify accuracy and timely completion of cleanroom documentation, batch records, and logbooks.
Ensure Genezen’s documentation meets cGMP, GDP, and company standards.
Develop, review, and approve SOPs and controlled documents for quality assurance.
Approve raw materials, test results, and Certificates of Analysis for production use.
Review batch records and assist in minimizing errors across departments.
Oversee final disposition of master cell banks and viral vector products.
Approve qualification/validation protocols, CAPAs, and stability protocols.
Lead GMP and GDP training for staff, including new hires and annual refreshers.
Conduct Root Cause Analysis for deviations and quality events, collaborating with teams to meet deadlines.
Manage label specifications, batch records, media fills, and stability protocols.
Oversee change management and internal audits, supporting customer/regulatory inspections.
Collaborate across functions to ensure products comply with approved procedures.
Qualifications
Bachelor’s degree in a science-related field.
Familiarity with regulatory standards such as 21 CFR Part 11, 21 CFR 210/211, 21 CFR 600/610, Eudralex Volume 4, ICH Quality Guidelines, and relevant industry guidance for early-phase clinical trials.
Experience with eQMS systems like Veeva.
Knowledge of clean room controls, aseptic processing, and EMA/ISO cleanroom standards.
Experience in early-phase clinical trial production and testing.
Background in startup CDMOs or Gene Therapy.
Minimum 2 years in a Quality Assurance role within the pharmaceutical or biologics industry.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Title: Quality Operations Associate
Company: Harba Solutions Inc.
Location: Indianapolis, Indiana, USA
Category: Quality Assurance – QA/QC, Healthcare (Data Scientist, Medical Science)
