Title: Quality Engineer / QA Support Specialist Location: Indiana, USA (Open to local residents only) Work Arrangement: Onsite Contract Duration: 6 Months – Contract to Hire Number of Positions: 4
Position Summary Our client is seeking Quality Engineer / QA Support Specialists to support quality assurance activities within a regulated manufacturing environment focused on the development and manufacturing of pharmaceutical packaging and drug delivery solutions, including injector systems. The ideal candidates will have a minimum of a bachelor's degree in Engineering or a Science-related field and at least 4 years of relevant experience within the pharmaceutical industry. Candidates should have experience supporting Quality Management Systems (QMS), reviewing quality documentation, and ensuring compliance with established quality procedures and applicable regulatory requirements. Experience with molding and assembly of injector devices, as well as process validation activities, is preferred.
Key Responsibilities
- Support daily Quality Assurance activities within a regulated manufacturing environment.
- Review and support Quality Management System (QMS) documentation, including CAPAs, deviations, Change Controls, and Batch Record Reviews.
- Assist with quality investigations, documentation reviews, and follow-up activities to support timely resolution and compliance.
- Support manufacturing quality activities related to the molding and assembly of injector systems.
- Participate in process validation activities and support the execution and review of Process Performance Qualification (PPQ) protocols.
- Ensure quality documentation is complete, accurate, and aligned with established procedures.
- Collaborate with cross-functional teams to support manufacturing operations and quality objectives.
Required Qualifications
- Bachelor's degree or higher in Engineering or a Science-related field.
- Minimum of 4+ years of relevant professional experience within the pharmaceutical industry.
- Experience working in a regulated pharmaceutical manufacturing environment.
- Knowledge of Quality Management Systems (QMS) and quality documentation.
Preferred Qualifications
- Experience with CAPAs, deviations, Change Controls, and Batch Record Reviews.
- Experience with molding and assembly processes for injector devices.
- Experience supporting Process Validation activities and executing PPQ protocols.
- Strong documentation, organizational, analytical, and communication skills.
- Ability to work effectively with cross-functional manufacturing and quality teams.
Interested candidates: Please share your updated resume for consideration.