Vacancy caducado!
Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Associate for a Contract assignment with one of our premier Pharmaceutical Services clients in Tucson, AZ. Responsibilities :
- Responsible for real time stability testing to support expiration dating of company reagents, as packaged under recommended storage conditions, to ensure that label claims are met throughout a product's shelf life.
- Work closely across company functions, including Life Cycle, Development, Operations/Manufacturing, Quality, and Regulatory.
- Support commercialization of new products and post-launch monitoring of on-market products through real time stability studies
- Coordinate with Development and other stakeholders to provide input on stability protocols, accept product transfers, conduct time point testing, and write stability reports.
- Help coordinate new product transfers from Development. Conduct failure investigations.
- Monitor products as packaged under recommended storage conditions over a period of time, with periodic testing to confirm that products meet specifications.
- Data management and participation in evaluating and reporting results.
- Assist in preparing data for inclusion in Stability Reports for FDA submissions.
- Generate required documentation/procedures in support of daily activities.
- Bachelor's in Science with 2+ years' experience.
- Executive Committee approval is required if degree is in a non-scientific field.
- Strong communication skills.
- Must have the ability to adhere to design control procedures in compliance with FDA and ISO guidelines.
- Ability to follow Quality System regulations, including Design Control, Stability protocols.
- Requires excellent communication, technical writing, and oral presentation skills.
- Multitasking and having excellent organization skills, as well as orientation to detail is essential to this position.
- Skilled at using Microsoft Word and Excel.
- Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought.
- Strong understanding of scientific principles and concepts.
- Applies advanced technical writing skills to produce reports and documents.
- Background in immunohistochemistry, histology/pathology, pharmaceutical chemistry, biology, biochemistry, or biomedical engineering is highly preferred.
- Experience from the medical device and/or pharmaceutical industries is preferred.
Vacancy caducado!