Quality Assurance Specialist – GMP, FDA Liaison & Projects

RXinsider LTD.; Bedford (OH); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Paid time off (PTO)

Holidays

Health, dental, vision

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Quality Assurance Associate to perform field QA activities, including in-process checks, AQL inspections, and batch record reviews. You will ensure GMP compliance and support final product release with guidance to manufacturing staff.

The role requires strong QA background, experience with regulatory audits, and ability to write/ revise SOPs and forms. Onsite work and collaboration with cross-functional teams are essential.

Qualifications

• Bachelor’s degree in a relevant science or engineering discipline; associates degree with equivalent experience acceptable.
• 4+ years of relevant cGMP experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.
• Experience with batch record review, product disposition, and SOPs is a plus.

Responsibilities

• Perform in-process checks, QA approval for area clearance for labeling and packaging.
• Conduct AQL inspections of finished products and QC lab sampling.
• Review batch records and ensure compliance with procedures; resolve discrepancies.
• Lead small projects and train junior staff.
• Interact with FDA and regulatory groups and support GMP events.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Project management

Documentation

Writing skills

Communication skills

FDA interactions

Problem solving

Time management

Education

Bachelor’s degree in science or engineering

Associates degree or equivalent

Tools

Microsoft Office

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Quality Assurance Associate to perform field QA activities, including in-process checks, AQL inspections, and batch record reviews. You will ensure GMP compliance and support final product release with guidance to manufacturing staff.

The role requires strong QA background, experience with regulatory audits, and ability to write/ revise SOPs and forms. Onsite work and collaboration with cross-functional teams are essential.