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Quality Assurance Specialist

Payrate: $43.00 - $43.00/hr.

Summary:
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.

Education and Experience:

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.).

Skills Requirements:

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, OneNote, PowerPoint)
Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, 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
One Approach
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

Pay Transparency: The typical base pay for this role across the U.S. is: $43.00 - $43.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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