IPQA Associate

Quality Assurance Durham, North Carolina


Description

DETAILED JOB DESCRIPTION

  • Perform all required in-process testing & sampling of batches in progress and products to be packaged.
  • Perform line clearances of the manufacturing/ packaging areas  and equipment
  • Verify and confirm issuance and reconciliation of product and components.
  • Performing cleaning verification/validation swabbing of equipment
  • Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition
  • Handle various requests from departments for developmental or investigative reasons
  • Capture critical information for Customer Complaint/Deviation investigations/ CAPA (when necessary)  
  • Review and approve preventive maintenance or work orders; (if necessary)
  • Participate in stability/validation product sampling
  • Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.
  • Complete all applicable training forms in a timely manner and forward to document control for archival
  • Data entry of finished product information into the APR (Annual Product Review ) system
  • Collection and inventorying of Retain and/ or Stability Samples
  • Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)
  • Replace Temperature/Humidity Charts weekly if applicable
  • Maintaining IPQA supply inventory
NOTE:  The duties in general include but are not limited to the above job functions and may change at the discretion of the QA Management.

REQUIRED:
  • 1-3 year 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
  • Possess the ability to analyze information and make consistently good decisions 
  • HS Diploma
  • Experienced in proper documentation and correction practices
  • Read, write and speak English
ANY REQUIRED LICENSES/CERTIFICATIONS
  • A familiarity with cGMPS, CFRs, OSHA and FDA regulations
  • Experience with deviations /incidents and CAPA

 PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

  • 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.