Quality Engineer

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

Job Title: Quality Engineer

Location: Bedford, Ohio

Job Type: Full-time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB SUMMARY:

The primary focus of this position is the creation and maintenance of control groups and inspector training/qualification sets. Other tasks may include review of investigations for quality related events triggered through the manufacturing process. Provide feedback to the investigation writer on the quality of the report with emphasis on compliance to SOP’s and cGMP. Must be the subject matter expert in the auditing/investigative process and provide the necessary leadership to assure continuous improvement in the mitigation of events associated with the manufacturing process. Independently lead Quality Engineering projects including identification of projects, definition of project scope, writing Change Controls, creating Engineering required documentation, and project tracking. Review and approve Quality documents such as SOPs, Change Controls, and QTO protocols, GTRs, Engineering Drawings, Maintenance Work Requests/Work orders, Inspector Qualification/Re-qualification, and challenge group creation and maintenance.

RESPONSIBILITIES:

• Generate control group samples for newly commissioned / validated inspection lines
• Generate control group samples for established inspection lines
• Maintain control group inventory
• Recertify samples within required timelines
• Generate and maintain Inspector Training Sets
• Ensure SOPs / Work Instructions are updated 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 in a timely manner to ensure compliance and timely product release and internal deadlines are met.
• Individual to provide direction for process improvements or preventative measures to avoid or minimize process deviations consistent with business requirements.
• Gather, assess, and distribute daily, weekly and monthly metrics.
• Perform QA Investigations or other assigned investigations as required.
• Revise and train individuals on the SOP's relating to the investigation process. Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary.
• Identify and implement quality improvement projects.
• Lead projects to completion with minimal supervision. i.e., coordinate manual inspector training program and challenge group program.
• Review and approve Quality documents such as SOPs, Change Controls, QTO protocols and GTRs

QUALIFICATIONS:

• Must have excellent verbal and written communication skills, sound judgment and analytical skills to enable assessment of risk.
• Resourceful, self-reliant, self-motivated and confident. Ability to work independently and be flexible to changing priorities. Strong personal computer skills.
• Must have excellent teamwork and organizational skills.
• Must have Science /Engineering background and demonstrated ability to manage and complete projects.

EDUCATION/EXPERIENCE:

• Bachelor’s degree in science/engineering with experience in an engineering or scientific (pharmaceutical manufacturing) discipline.
• 3 to 5 years experience in the areas of GMP regulations.
• Previous auditing experience is a plus.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.