Quality Engineer: GMP Audits & Process Improvement

RXinsider LTD.; Bedford, Northern (OH, KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

11 company holidays

Health benefits

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Quality Engineer to develop and maintain control groups for inspection lines and to lead QA investigations ensuring compliance with SOPs and cGMP. The role involves auditing, project leadership, and documentation across quality systems.

The candidate should have a science/engineering background, 3–5 years GMP experience, and the ability to drive continuous improvements in manufacturing quality and product release timelines.

Qualifications

• Excellent verbal and written communication; strong analytical skills.
• Ability to work independently with changing priorities.
• Experience with GMP regulations and QA processes.

Responsibilities

• Create and maintain control group samples for inspection lines.
• Maintain control group inventory and recertify samples on schedule.
• Prepare and manage Inspector Training Sets and qualification activities.
• Review investigations for quality events and ensure timely product release.
• Lead QA projects and document Change Controls and SOPs.

Skills

Communication skills

GMP knowledge

Auditing experience

Education

Bachelor’s degree in science/engineering

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Quality Engineer to develop and maintain control groups for inspection lines and to lead QA investigations ensuring compliance with SOPs and cGMP. The role involves auditing, project leadership, and documentation across quality systems.

The candidate should have a science/engineering background, 3–5 years GMP experience, and the ability to drive continuous improvements in manufacturing quality and product release timelines.