Description:
This is a Quality Assurance role focusing on record review and control, document change control, and equipment management.

Specific Requirements:
This position is a Quality Assurance role in a manufacturing group that produces components for in-vitro diagnostic assays. A BS in Life Science or equivalent experience is required. Applicants with experience in a GMP/ISO regulated environment preferred. Applicant should be familiar with Good Documentation Practices. The successful candidate will demonstrate exceptional attention to detail and professional demeanor.

Key Responsibilities:
Management of document control systems, including review of documents and processing changes
Manage quality record archives
Perform final review of device history records (DHRs) at a high level of detail
Perform batch disposition in SAP system
Maintain metrics for batch records and document control systems as applicable
Perform review of equipment service records, including updating information in the electronic equipment management system
Perform review of validation documentation for successful completion and GDP
Support of other Quality Assurance responsibilities as needed

Preferred Knowledge/Skills, Education, Experience:
Experience in a regulated environment (21 CFR 820 and/or ISO 13485)
Equipment validation and service management (CAL/PM)
Technical writing
SAP Quality Management experience