Job Details

  • Title: QA Specialist
  • Code: RCI-09435
  • Location: San Dimas California (CA) 91773
  • Posted Date: 02/23/2021
  • Duration: 6 Months
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  Job Description

  • Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology
  • Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability
  • Performs a variety of activities to ensure compliance with applicable regulatory requirements
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
  • Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives
  • Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support
  • Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
  • May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products
  • Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required
  • Interfaces with contract manufacturers and suppliers to address documentation and compliance issues
  • Normally receives general instruction on routine work, detailed instructions on new assignments
Knowledge
  • Should have previous experience in pharma, ideally bulk processing and aseptic processing, and/or investigations experience would be ideal
  • Must have an understanding and application of QA principles, concepts, industry practices, and standards
  • Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis
  • Must have strong writing skills to present findings in a clear and concise manner
  • Must be detail-oriented and able to demonstrate a high standard of integrity
  • Must have a desire to demonstrate excellence by setting high standards
  • BS/BA degree and a minimum of 2-3 years of relevant experience. QA experience preferred, educational background in the sciences (Engineering, Biology, Chemistry)
  • With guidance exercises judgment within well-defined and established procedures and practices to determine appropriate action
  • Normally receives no instruction on routine work, general instructions on new assignments
  • Strong verbal, technical writing, time management and interpersonal skills are required