We have an immediate opening for an experienced QA Chance Notification Coordinator for a biomedical company in the city of Santa which specializes in cell therapy and regenerative medicine. The position is temp-to-hire and pay range is $20 to $23 to start. Schedule is 1st shift 8:00 am to 5:00 pm Monday through Friday
Coordinate processing communication and qualification of external and internally generated material changes or process changes to customers.
Back up for batch record review, raw material inspection, quality trending, and non-conformance coordination
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Coordinate processing, qualification and communication of external and internally generated material changes or process changes to customers.
· Communicating to customers changes made by Irvine Scientific and answering any related customer questions.
· Coordinating with other departments to complete material qualifications
· Review of batch records and Inspect labeling and storage conditions of product
· Assists with maintaining the non-conforming material log, files and database
· Assist in the preparation of all controlled documents (generating CRs as needed)
· Review and improve processes as needed (provides training as needed)
· Maintains Device History Records files and database
· Collaborates with other departments to meet customer requests
· Lot folder scanning
Review and verify all documentation in the batch record and maintain database for the QA Final Release History.
· High school diploma or equivalent; basic understanding of mathematics and chemistry necessary.
· Two years of college in a science discipline is preferred.
· A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent.
· Proficiency in current versions of MS Word, Excel, Outlook, PowerPoint Computer skills
· Strong communication/project management skills
· Basic knowledge of Chemistry and related USP specifications
• Current industry regulations, i.e. detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations and inspection and auditing guidelines.
• Change notification and chemistry knowledge needed.
• LANGUAGE SKILLS REQUIRED
• Ability to speak, read, and write English.
• Excellent oral and written communication skills.
• TRAINING REQUIRED
• Refer to Quality Systems Manual, QSM-001.
Staffing Solutions goal is to consistently provide our clients with value added service which will enable them to achieve the highest level of success and profitability.
Our executive staff members have over twenty years of experience leading the industry's premier staffing organizations. Our broad expertise encompasses;
Role: QA Change Notification Coordinator
Location: Santa Ana,
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