Quality Engineer
Hikma Pharmaceuticals
full-time
Posted on:
Location Type: Office
Location: Bedford • Ohio • United States
Visit company websiteExplore more
Salary
💰 $66,600 - $133,750 per year
About the role
- 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.
Requirements
- 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.
- 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.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Engineeringauditinginvestigative processChange ControlsSOPsQTO protocolsGTRsEngineering DrawingsMaintenance Work RequestsInspector Qualification
Soft Skills
verbal communicationwritten communicationanalytical skillsteamworkorganizational skillsself-relianceself-motivationflexibilitysound judgmentindependence