QUALITY ASSURANCE ASSISTANT- PHARMACEUTICAL
Location: North Augusta, SC, SC
Name: Jennifer Gibson
Phone: 803-442-7590 Ext. 405
QUALITY ASSURANCE ASSISTANT
****PLEASE READ QUALIFICATIONS AND REQUIREMENTS AS ONLY QUALIFIED APPLICANTS CAN BE CONSIDERED**
Specific Duties and Responsibilities:
· Assist in the development and maintenance of document filing systems for storage of controlled documents
· Issuance of laboratory notebooks, and the creation and issuance of logbooks
· Distribute new or revised procedures
· Maintain History Files for all SOP's, Certificate of Analysis, Specifications and other documentation as necessary
· Fulfill controlled document requests and maintain the logbook for issuance of the documents
· Issuance of data record sheets
· Issue Master Batch Records and Production Records
· Scanning and management of controlled records.
· Responsible for drafting a Certificate of Analysis according to the QA approved analytical data
· Other responsibilities as assigned
· COLLEGE DEGREE REQUIRED
· Problem solving and decision-making capability.
· Ability to effectively communicate at all levels of the organization.
· Knowledge of GMP and safety regulations.
· Ability to facilitate problem identification and solution sessions with minimal support.
· Good planning and organizing skills.
· General understanding of World Class Manufacturing.
· Must exhibit the flexibility needed to respond to frequent changes in production requirements and/or systems and equipment failures.
· Awareness of OSHA regulations, GMP, facility safety regulations.
· Must be able to push, pull, squat, stand and walk through-out the day
· Must be able to lift up to 20lbs