Great opportunity to work as a Quality Engineering Specialist at a Global, research-driven pharmaceutical manufacturer focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. This is an amazing opportunity to work on cutting edge treatments and make a difference!
Quality Engineering Specialist
15 month contract (Extension or conversion potential)
Monday to Friday 8-5
Benefits: Medical, Dental, Holiday, PTO 401K matching
Quality Engineering Specialist
The Quality Engineering Specialist provides quality assurance support for manufacturing operations and site capital projects. This role serves as the quality lead for OPEX and CAPEX initiatives, supporting change controls, validation activities, and project documentation to ensure compliance with cGMP and internal quality systems.
Responsibilities
- Provide QA support for production, facilities, utilities, and capital projects
- Act as Quality Lead for OPEX/CAPEX projects, including change control and deviation support
- Review and approve quality and validation documentation
- Support equipment, facility, and utility commissioning and qualification
- Serve as a quality/compliance resource on cross-functional project teams
- Support issue resolution and promote a strong quality culture
Requirements
- 2-3+ years of experience in Animal or Human Health manufacturing or quality
- Strong experience with quality systems (change control, deviations, CAPA)
- Knowledge of vaccine or biological manufacturing processes
- Experience supporting equipment validation and capital projects preferred
- Bachelor’s degree in Life Sciences or Engineering
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
INDBH
