quality assurance specialist.

QA Specialist will be responsible for proper execution of its job according to expectations as defined in GMP, Quality, Regulatory and J&J Compliance guides and regulations.

QA Specialist will independently perform standardized tasks in accordance with official procedures and processes. The focus is on managing and support of the J&J Quality systems (e.g. documentation, training systems).

Key Responsibilities:

Documentation Management:

·      Acts as TruVault SME for system training, support and administration.

·      Reviews as SME documents for compliance with GMP regulations; guidance, company standards and other SOPs for impact on patient safety and product quality.

·      Acts as SME for internal and external archiving.

·      Manages issuance and archival of quality records like test records, external reports, logbooks etc. onsite and off-site for long term preservation, and provides content of superseded and obsolete documents upon request.

Training Management

·      Maintains the Learning Management System (LMS) in support of the operational departments.

·      Acts as first point of contact for training for the PDQ department and Departmental Training Delegates (DTD).

·      Organizes JVL Site based training, including maintenance of a matrix and coordinates the local training related procedures and ensures yearly training record review for department.

·      Supports Department Manager regarding training related responsibilities.

General Quality Systems support

·      Can act as Superuser for TruVault and other relevant J&J Quality systems.

·      Issuance of Initials to be used on company documents.