The Quality Assurance Associate I is responsible for supporting the administration of the Document Control Program. This responsibility includes Master Batch Record maintenance; batch record generation, issuance, collation, tracking, and scanning; Logbook generation, issuance, and return; document storage and maintenance; and QA Support as defined in the applicable SOPs.

Responsibilities:

• Maintain Master Production and Control Records
• Prepare, collate and issue log books and batch records
• Receive, reassemble and maintain in-process batch documentation
• Copy / Scan batch records and QMS documentation
• Route and track the progress of issued batch records as defined by management
• Responsible for document storage and maintenance of controlled documents
• Maintain Document status in Electronic Databases
• Coordinate activities for off-site Document storage

• Perform QA retain inspections, maintain office hours, and perform other Quality tasks as directed by management

Qualifications:

• High School Diploma or GED with one year relevant experience
• Understanding of cGMP documentation requirements
• Proficient with current word processing and database software
• A high level of integrity and attention to detail
• Must work efficiently
• Strong interpersonal skills and ability to communicate effectively