Quality Assurance Technician II

BioSpectra in Manufacturing Email Job

Job Description

Reports To:
  Quality Assurance Manager

 

 
Direct Reports:
  Not Applicable

 

 
Emergency / Absentee Backup:
  Quality Assurance (Technician I and II), QA Manager

 

 
Job Summary:
  The Quality Assurance Technician II is responsible for the inspection and release of processes and materials for use in GMP activity.  The QA Technician II is responsible for the issuance, review and approval of material records for material disposition.

 

 
Essential Duties and Responsibilities:
 
  • Scans/Files Quality Assurance related documentation as applicable.
  • Reviews and approves all Raw Material and Component sheets to ensure all records are complete.
  • Completes Quality Control Details for ERP system and ensures Quality records within ERP are accurate and complete.
  • Issues batch records based on work order issuance as stated in the ERP System.
  • Reviews and approves Batch Records for material disposition.
  • Issues product labels/seals and ensures accuracy in all accountability.
  • Issues cleaning worksheets based on the statuses of the manufacturing process rooms.
  • Completes Quality Control Details for all finished good material using the ERP system.
  • Performs review of month preventative maintenance records for completion and accuracy.
  • Obtains requested documents as necessary in support of an audit, department or customer request.
  • Assists in finding, copying, and filing paperwork needed for completion of various records.
  • Assists with the maintenance of Temperature and Humidity Monitoring Program supporting documentation.
  • Assists with the creation of various analytical tools, such as statistical analysis, to evaluate and interpret data.
  • Coordinates change control approval process and completes implementation requirements as instructed by Quality Assurance Management.
  • Performs Finished Good Inspection and/or QA Approval prior to Finished Good Shipments when not involved in product labeling activities.
  • Issues or Approves Certificate of Analysis for Finished Goods Shipments.
  • Approval of Raw Material within ERP system.
  • Places incoming components and raw material on Hold.
  • Ensures Good Documentation Practices are followed on all submitted documentation and logbooks.
  • Performs in process review of manufacturing documentation including logbooks, batch records, raw material usage sheets, etc.
  • Identifies documentation practice errors or concerns and immediately communicates the requirements for correction to specific personnel.
  • Identifies process or system deviations in real-time and communicates findings to Quality Assurance Management.
  • Performs Discrepancy investigations and provides investigation report to Quality Assurance Management.
  • Supports CAPA commitment closure as instructed by Quality Assurance Management.
  • Inspects process rooms to ensure each meets cleaning and use requirements before the start of a batch record.
  • Performs verifications in manufacturing processes as applicable based on training.
  • Assists with labeling of material and or out going shipments.
  • Formats documents in accordance with BioSpectra policies.
  • Other duties may be assigned as deemed appropriate by management.

 

 
Qualifications:
 
  • 2-year Associates Degree or approved equivalent experience in a cGMP environment
  • Understanding of cGMP & ICH-Q7
  • Knowledge of relevant software applications including MS Office and Minitab
  • Knowledge of office systems and procedures
  • Organized, Thorough, Neat
  • Must be able to read, write, speak, and understand English
  • Confidentiality

 

 
Physical Requirements:
 
  • Lift up to 20 lbs. occasionally
  • Prolonged periods sitting at a desk and working on a computer
  • Repeating motion that may include wrists, hands, and fingers

 

 
Work Hours:
 
  • Non-Exempt Position
  • Minimum of 8 Hour Shift from (6-2:30 or 2-10:30), 5 Days a Week, or other agreed upon documented schedule
  • Ability and willingness to work from all BioSpectra facilities

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