Tablet and Capsule QA Technician

Dayton, New Jersey
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 146720

Date Posted: 11/08/2019


Title:  IPQA Associate I & II
Hours:  Full Time, 2nd shift 
Location:  Dayton, NJ

Responsibilities:
IPQA Associate Level II will support and assist activities related to the production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.

  • 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 (with exceptions) 
  • Performs in- process checks and finish goods inspections to ensure product conforms batch record specifications 
  • Performs AQL Sampling Collects and submits Stability Samples from Manufacturing and Packaging operations 
  • Verify and confirm issuances and reconciliation of product and components. Inspects and releases printed packaging materials 
  • Revise SOP as needed 
  • Initiate Change Controls
  • Writes Protocols, CAPAS & Deviations as assigned and with guidance
  • Handle various requests from departments for developmental or investigative reasons
  • Master Label Creations 
  • Provides support to complete Annual Product Review 
  • Performs annual product visual inspections 
  • May participate in the execution of validation and process improvement activities

Qualifications:

  • Minimum of 3-4years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment
  • Familiarity with cGMPS, CFRs, OSHA and FDA regulations
  • Good communication skills and capable of communicate with all levels 
  • Able to work long hours to support production requirements 
  • Be available for overtime, including weekends, as needed for production support 

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
 


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