What are the responsibilities and job description for the Quality Engineer position at Commissioning Partners?
We are looking for a motivated and detail-oriented Quality Engineer to join our Quality team. This is an excellent opportunity for a recent graduate or early-career professional to build hands-on experience in a regulated manufacturing environment.
The ideal candidate will support quality assurance activities, documentation, investigations, and continuous improvement initiatives while working closely with Engineering, Manufacturing, Validation, and Quality teams.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, Pharmacy, Quality, or a related discipline.
- 0–2 years of experience in Quality, Manufacturing, Validation, or a regulated industry.
- Internship, academic project, or co-op experience in a GMP/regulated environment is a plus.
- Basic understanding of GMP, FDA regulations, and quality systems.
- Familiarity with documentation practices and quality processes.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a cross-functional team environment.
- Proficiency with Microsoft Office, including Word and Excel.
Preferred Skills
- GMP / cGMP
- Quality Management Systems (QMS)
- Deviations / Non-Conformances
- CAPA
- Change Control
- Root Cause Analysis
- Risk Assessment
- SOPs
- Audit Support
- Data Integrity / ALCOA
- FDA Regulations
- 21 CFR Part 11
- GAMP 5