Marketing Document Control Specialist Jobs in Indiana

Manage vendor documentation (Vendor Qualification Reports, CoAs, SDS).

Manage the approval and archival of SOP, WI, Process Flows, CAPA, OOS, deviations, nonconformance, complaints and investigation as required.

Support validation and qualification of process equipment, lab equipment, stability chambers, cleaning, and utilities.

Manage New Equipment Asset lists and assign numbers for all new equipment added to the facility.

Five years’ experience in GMP environment with relevant Quality Assurance/Compliance experience

Knowledge of FDA 210, 211 and ISO 13485, 9001, 22716 preferred

Prepare document templates, document business rules, roles and responsibilities.

Two to three years of experience in documentation preparation and filing preferred but not required

Competitive compensation and benefits package

Meet with business process owners to define the appropriate document standards and workflows.

Supervise the document lifecycle for business policies and procedures.

Collect and maintain files of the latest revision level documentation necessary to define product configuration and control mfg. processes.