Catalent, Inc. is looking for a Quality Inspector to ensure that Standard Operating Procedures are consistently followed and that cGMPs are observed in packaging operations, as well as to verify and reconcile materials, inspect and release packaging rooms, and review batch records and associated paperwork for documentation errors.
Requirements
- Good knowledge of the application of FDA cGMP’s.
- Ability to quickly learn and implement QA Auditing techniques.
- Knowledge of MS Office and Inventory Management system are a plus (JD Edwards 9.1 preferred)
- Basic knowledge of Lean Six Sigma methodologies an advantage
Responsibilities
- Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP’s are observed, in the course of packaging operations. This may require the simultaneous auditing and/or monitoring of one or more operations.
- Verifies and reconciles materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.
- Inspects and releases all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.
- Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.
- Reviews and understands both the Production Protocol and QA Protocol prior to starting the Clinical Packaging process.
- Performs and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA Protocol and SOPs requirements as well as ensuring that the Production Protocol and GMP standards are being followed.
- Reviews the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.
Other
- Bachelor’s degree preferred OR a minimum of 3 years of Production/QA experience.
- Proven track record of monitoring/auditing for Quality and of identifying potential efficiencies in a Production environment.
- Good Communication Skills, both written and verbal.
- Strong interpersonal skills and is comfortable working in a team environment.
- Exercises sound judgment and are analytical in thought.
- Comfortable working in a dynamic environment with many conflicting priorities?
- This is an onsite, full-time, hourly role position: Monday-Friday: 3:45pm-12:15am - 2nd shift (weekends as needed)
