CareersUSA, a leader in the staffing industry with over 38 years of experience, has another job opportunity for you:
Our Client is seeking a Quality Inspector - Production in Philadelphia, PA.
Earn $18.00 to $21.00 per hour at this full-time, temp-to-hire position. Work 40 hours per week, Monday through Friday at the following schedules:
- 10:30 AM to 6:30 PM
- 12:00 PM to 8:00 PM
Job Summary:
The Quality Inspector is responsible for process monitoring and auditing of packaging operations with duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, managing deviations and investigations to resolution and completion. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances and room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement in partnership with Production personnel.
Job Description:
- Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP’s are observed in the course of packaging operations
- Verify and reconcile materials to and from clinical production rooms and work accordingly with Production, Materials Management and Project Management to handle any possible discrepancies
- Inspect and release all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Document all activities accordingly in the associated logbook
- Support and assist 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
- Review and understand both the production protocol and QA protocol prior to starting the clinical packaging process
- Perform and document 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
- Review 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
- Review EMS system printouts for out of specification temperatures, humidity and pressures
- Print and review Material Usage Reports for each clinical packaging job and/or operation to ensure that the drug product quantities documented in the batch record match those that are entered in the Inventory Management System
- Ensure that all Inventory Management System printed labels are correct against the information provided in the associated protocol
- Update the daily/shift QA turnover log with all pertinent information regarding activities during the assigned rooms and shifts and forward relevant notes via email to all pertinent employees
- Perform walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed
- Review production logbooks for GMP compliance as each operation is completed and revise SOPs as needed
- Partner with other departments in resolving unplanned deviations, investigations and in troubleshooting. Drive deviations and investigations to completion
- Perform additional sampling/testing protocols on clinical trial materials as requested by the customer
- Perform equipment parts inspection, approval and storage as required per SOPs
- Inspect and verify that all clean storage rooms meet approval criteria as per our SOPs
Requirements:
- High School Degree or Equivalent (GED)
- Bachelor's Degree preferred
- 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 computer skills
- Knowledge of Microsoft Office and Inventory Management System are a plus
- Basic knowledge of Lean Six Sigma methodologies an advantage
- Good knowledge of the application of FDA cGMP’s
Contact Information:
Recommended skills
Storage (Warehousing)
Product Quality Assurance
Packaging And Labeling
Auditing
Certified Global Meeting Planner
Good Manufacturing Practices