IPQA Associate Level III (2nd shift)


Job ID 19-00075

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

Duties:

  • Certificate of Analysis Review/Approvals
  • Performing Cleaning Verification/Validation Swabbing of Equipment
  • Capture critical information for Customer Complaint/Deviation investigations/ CAPA (when necessary)
  • Perform complaint sample inspection
  • Conducts and verifies line clearances (Rooms / Equipment) and components verification
  • Review and Approve Preventive Maintenance or Work Orders (if necessary)
  • Monitors compliance in Manufacturing, Packaging, Product Development/Technical Services (PDTS) and Warehouse areas
  • Blend sampling
  • Performs in- process checks and finish goods inspections to ensure product conforms batch record specifications
  • Performs AQL Sampling
  • Provides quality direction to resolve floor issues, implement correction
  • Writes and revises SOP as needed
  • Initiate Change Controls
  • Writes Protocols, CAPAS & Deviations as assigned
  • Handle various requests from departments for developmental or investigative reasons
  • Master Label Creations
  • Approves Protocols/Change Controls if needed with QA Management guidance
  • Provides support to complete Annual Product Review
  • Performs annual product visual inspections
  • May participate in the execution of validation and process improvement activities
  • Training of new personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) Complete all applicable training forms in a timely manner and forward to document control for archival
  • Participates in site quality and process improvement
  • Perform batch record QA final review under Batch Record Coordinator's supervision, if needed


Qualifications

Qualifications:

  • High School Diploma or equivalent GED
  • Attention to detail, strong organizational skills and time management Must have knowledge of cGMPs and Good Documentation Practices
  • Read, write and speak English

 

Required:

  • Over 5 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
  • Communication skills (written and verbal). Effectively communicate with other department on different levels
  • Be able to work long hours to support production requirements
  • Be available for overtime, including weekends, as needed for production support
  • Possess the ability to analyze information and decision making

 

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.