Website CYNET SYSTEMS
CYNET SYSTEMS
Company : CYNET SYSTEMS
Job Description:
Pay Range: $24hr – $25hr
Responsibilities:
- Collects current equipment documentation to fill gaps or identify missing information.
- Working with Validation Engineers and quality assurance document control to implement necessary improvements.
- These may include modifications to existing documents, or collection and filing of current documents.
- Supports validation protocols for data collection, or creating documents, as assigned.
- Maintains compliance with regulatory agency guidance and client procedures.
- Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
- Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
- Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use.
- Supports on-going system requalification and continuous improvement activities governed by change management processes.
Skills:
- Possess an understanding of documentation organization, and ideally in a GMP environment.
- Must have excellent verbal and written communication skills, attention todetail, and problem solving skills.
- Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc.
- Desirable to also have some basic mechanical skills.
- Preferred understanding of statistical analysis tools and/ or analytical methods.
Education/Experience:
- BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
- 0 – 2 years pharmaceutical manufacturing experience.