Quality Engineer — GMP Investigations & Training

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with employer match

PTO 20 days (+ milestones)

3 personal days

Comprehensive benefits (health, dental

Employee discount program

Safety and Quality priority

Career advancement opportunities

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Quality Engineer to lead the creation and maintenance of control groups and inspector training sets.

You will review investigations for quality events, ensure SOP compliance, and drive continuous improvement in manufacturing processes, with responsibility for Change Controls and related documentation. Ideal candidates have a science/engineering background, 3–5 years GMP experience, and strong project leadership skills to guide quality projects from

Qualifications

• Must have excellent verbal and written communication skills.
• Ability to manage and complete projects.
• Experience in GMP regulations is a plus.

Responsibilities

• Generate control group samples for newly commissioned/validated inspection lines.
• Generate control group samples for established inspection lines.
• Recertify samples within required timelines.
• Generate and maintain Inspector Training Sets.
• Update SOPs/Work Instructions to reflect control group additions/revisions.
• Issue samples to Inspection and Packaging.
• Coordinate with Operations to schedule time to certify samples.
• Coordinate with Operations to schedule water/placebo runs as needed.
• Review, revise and approve investigations to ensure compliance and timely product release.
• Provide direction for process improvements or preventative measures.
• Gather, assess, and distribute daily, weekly and monthly metrics.
• Perform QA Investigations or other assigned investigations.
• Revise and train individuals on SOPs relating to investigation processes.
• Identify and implement quality improvement projects.
• Lead projects to completion with minimal supervision.
• Review and approve Quality documents such as SOPs, Change Controls, QTO protocols and GTRs

Skills

Communication skills

Analytical thinking

Teamwork

Project management

Independent work

Education

Bachelor’s degree in science/engineering

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Quality Engineer to lead the creation and maintenance of control groups and inspector training sets.

You will review investigations for quality events, ensure SOP compliance, and drive continuous improvement in manufacturing processes, with responsibility for Change Controls and related documentation. Ideal candidates have a science/engineering background, 3–5 years GMP experience, and strong project leadership skills to guide quality projects from