ABOUT COMPLIANCE TEAM

Since 2003, our life science compliance consultants have helped pharmaceutical and medical device manufacturers bring lifesaving products to market. We provide engineering validation services and FDA regulatory affairs services to life science companies across the United States. We are seeking a creative, collaborative, and hands-on worker to provide quality support in a large manufacturing environment. We value personal accountability, corporate transparency, and professional development – a positive customer experience is as important as a positive employee experience.  We thrive on hard work and fun!

Position Description

Our client, a contract manufacturer for medical devices, is seeking Validation support for their facility build-out. This is a hybrid position, with time on-site as necessary to perform support of Validation and Qualification activities and creation and approval of deliverables. All assignments will be given and managed by the Compliance Team Lead.

 Activities include:

• Creation of IOQ documents, and potentially SOPs from approved templates and manuals
• IOQ Execution, as applicable, identified in system validation docuemnts
• Completion and approval of final reports.
• Continually-shfiting priorities as project needs evolve. 

 This position is expected to be of three-month duration.

Qualifications

The ideal candidate will have the following skills and experience:

• 5-10 years experience in project management, oversight, scheduling, and coordination for validation and/or capital projects
• Hands-on validation experience with utilities, process equipment and facilities equipment and systems
• Generation, execution, and reporting on IQ/OQ/PQ protocols
• Working knowledge of quality management systems, including 21 CFR 820 and ISO 13485.
• Ability to communicate (in oral and written forms) in a concise, clear and accurate manner.
• Proven ability to work constructively with a broad range of people, backgrounds, and functions.
• Proficient with basic word processing and spreadsheet software, as well conferencing applications.

PHYSICAL REQUIREMENTS:

• Ability to walk down equipment in an industrial production setting - including walking on wet floors, stooping and operating multi-level equpment (stairs).
• Ability also to sit for extended periods of time at a computer terminal.
• Drug test and pre-employment background check will be required to be eligible for hire.