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