Quality Assurance Associate I — Compliance & Data Integrity

Octapharma Plasma, Inc.; Charlotte (NC); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Paid time off

Tuition Reimbursement

Employee assistance program

Wellness program

HSA

Job summary

Octapharma Plasma, Inc. is hiring a Quality Assurance Associate I to support regulatory notifications, data review, and collaboration with Donor Centers.

The role emphasizes adherence to cGMP, Lookback rules, and CAPA processes while ensuring documentation is complete across the organization. The ideal candidate will have QA experience, strong attention to detail, and the ability to work within a fast-growing plasma production environment.

Qualifications

• One (1) year of quality assurance experience preferred.
• High School Diploma required; Bachelor’s degree preferred.
• Practical working knowledge of quality assurance.
• Knowledge of cGMP regulations, especially 21 CFR Parts 210, 211, 600.
• Understanding Lookback requirements under 21 CFR Part 600 preferred.
• Strong proficiency with office software.
• Detail-oriented with ability to follow detailed instructions.
• Excellent time management and organizational skills.
• Self-starter with professional demeanor and customer service focus.
• Ability to monitor progress and work as part of a team.

Responsibilities

• Complete customer notifications, including lookback notifications and CD reports.
• Report customer notifications to regulatory agencies and assist with disposition of affected products.
• Collect, compile, and review data.
• Communicate with Donor Centers to obtain information and documentation.
• Prepare, review, and submit lookback notifications as required.
• Submit eBPDRs to the FDA.
• Generate quarantine files for automated product holds.
• Collaborate with Corporate Validation on product temperature excursions.
• Assess final product disposition and report approvals/denials.
• Maintain document control procedures and TOCs.
• Support audits and regulatory inspections by gathering information.

Job description

Octapharma Plasma, Inc. is hiring a Quality Assurance Associate I to support regulatory notifications, data review, and collaboration with Donor Centers.

The role emphasizes adherence to cGMP, Lookback rules, and CAPA processes while ensuring documentation is complete across the organization. The ideal candidate will have QA experience, strong attention to detail, and the ability to work within a fast-growing plasma production environment.