QA Specialist

SHIFT - MON-FRI 8AM - 4:30PM - DURATION - 3 MONTHS -

The San Diego Clinical and Specialty Services (CSS) Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.

• Bachelor’s degree required or equivalent relevant work experience.
• 5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• JD Edwards or comparable ERP systems preferred.
• Minimum of 3 years of customer service experience.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

• Receives instruction, guidance and direction from others
• Uses existing procedures to solve routine problems
• Proactive to address work issues at the individual level
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Ability to work effectively under pressure to meet deadlines
• Sufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, One Note, PowerPoint)
• Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, Track Wise, Smartsheets).
• Proficient in Adobe Acrobat
• Proficiency in all QS I items
• Proficient in JDE
• Able to create Certificate of Analysis independently
• Inspection of bulk drug and finished product
• Adhere to GMP standards routinely with limited errors and limited guidance
• Able to help with investigations
• Able to communicate to other teams about requirements
  
  Perform effective rapid response
• Subject Matter Expert in JDE related to MMQC processes
• Inspection of all incoming material types
• Investigation and Deviation writing proficient
• Authoring/Updating documents related to MMQC
• Approval of GSA jobs
• Independent release of labels for use
• Approve label prints
• Approve external label request forms
• Verify variable data
• Perform effective rapid response
• Subject Matter Expert in JDE related to label release
• Investigation and Deviation writing proficient
• Authoring/Updating documents

• Assist with DME training for new associates
• Reviewing/approving Deviations and Complaints
• Perform effective rapid response
• Attend/prepare for BRMs
• Client comment resolutions with assistance
• Drive effective rapid responses
• Complaint assessment
• Presentation of Quality items to clients and ELT
• Assist with other site/global quality items
• Authoring/Updating documents
• Train QS I and II associates
• Reviewing / approving engineering studies
• Review/ approval of Periodic reviews and requalification
• Reviewing /approving change controls and change actions
• Perform effective rapid response
• Presentation of Quality items to clients
• Assist with other site/global quality items