About this role
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 EMs and PMs 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