IPQA Associate Level I

Quality Assurance Dayton, New Jersey Dayton, New Jersey


Description

Duties:

 

  • Conducts and verifies  line clearances (Rooms / Equipment)  and components verification
  • Performs  in- process checks and finish goods inspections to ensure product conforms batch record specifications
  • Performs AQL Sampling
  • Verify that temperature/humidity and Magnehelics are all in range/good working condition
  • Collects and submits Stability Samples from Manufacturing and Packaging operations
  • Collection and storage of retain samples
  • Perform water readings and instruments verification
  • Verify and confirm issuances and reconciliation of product and components
  • Checks calibration tags/stickers on process equipment
  • Inspects and releases printed packaging materials

 

 

  • Inspects incoming and outgoing materials for proper identification and conformance with specifications
  • Regularly review and maintain logbooks and forms
  • Initiates Deviation & CAPAs as needed
  • Handle various requests from departments for developmental or investigative reasons

 

                                                                        

  • Provides support to complete Annual Product Review

 Qualifications: 

  • High School Diploma or equivalent GED
  • Ability and willingness to learn manufacturing/packaging procedures and federal      regulations pertaining to manufacturing process
  • Experienced in proper documentation and correction practices
  • Read, write and speak English
Required: 
  • Minimum of 1-2 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
  • Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals
  • Be able to work long hours to support production requirements
  • Be available for overtime, including weekends, as needed for production support

Physical requirement:
  • Stand/walk for the majority of the shift.
  • Must be able to bend at the waist and knees as well as twist at the trunk.
  • Must practice good personal hygiene
  • Must be able to lift up to 30 lbs.