The Process Control Inspector is responsible for the product process monitoring activities in the filling, bulk, and packaging areas. Responsibilities include: product inspections, line clearance, product reconciliation, and supporting documentation. The Process Control Inspector also works as part of a team on a rotating shift basis.

Responsibilities:

• Performs line clearance both prior to the start up of lot production and before resuming manufacturing activities after stopping the production line for corrective actions


• Responsible for QC sampling (retains, nova septum and QC laboratories)


• Verification and release of BFS code magazine


• Perform resin verification


• Maintain/ Review batch record documentation of all inspection activities


• Conduct and document Daily EM’s and PM’s activities, including line clearance offillsuite


• Complete inventory transactions in ERP


• Weigh and document scrap ampoule counts for product reconciliation


• Complete documentation for product defects, investigation and resolution of deviations, and corrective actions


• Just in time review of filling, packaging, and process control sections of batch records


• Participate in all internal and external HI Training Programs


• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines

Qualifications:

• High School Diploma or GED


• Proficient with current word processing and database software


• Knowledge of basic statistical sampling plans and calculations


• Strong interpersonal skills and ability to communicate effectively.


• Ability to develop team oriented working relationship within team operation