Quality Assurance Associate at The Judge Group Inc. in South San Francisco, California

Job Description:

Location: South San Francisco, CA

Salary: $105,000.00 USD Annually - $130,000.00 USD Annually

Description: Our client is currently seeking a Quality Assurance Associate
[The Quality Assurance Associate will provide support for internal and external activities to support GxP operations. This role's primary functions include management of training, electronic systems document control, coordination of periodic review of SOPs, the approved supplier/vendor qualification schedule, maintenance of electronic tracking systems for GMP supplier analytical documentation, review of release and stability data and notifying management of trends, tracking the status of quality agreements and product quality complaints, and participating in internal audits of Client Quality Systems and Records.


]


This job will have the following responsibilities:

• Key responsibilities of this role include, but are not limited to:
  
  
  •Training - Ensure all GxP training records and training matrices are available and maintained. Manage the electronic training tracker. Conduct training of client personnel on standard operating procedures if requested by Quality management. Coordinate new employee training with affected departments, Human Resources and Quality Assurance.
  
  
  •Document Control - Maintain electronic document change control logs, route of documents to personnel for review and approval, coordinate periodic SOP reviews and ensure its completion, and archive obsoleted documents. Send out training notices to employees and consultant(s) for new and revised standard operating procedure as well as send follow-up training reminders as needed.
  
  
  •Quality Operations - Maintain electronic trackers related to deviations, change controls, CAPA, Out of Specification investigations, product complaints, following up on open records to ensure timely completion.
  
  
  •Analytical Quality Support - Attend and participate in calls with client GMP suppliers. Track progress of the review and approval of analytical method transfers, method validations, laboratory and out of specification investigations. Maintain records of GMP documentation in client electronic data storage platform. Review stability data and notify Quality management of trends and out of specification results.
  
  
  •GxP Supplier / Vendor Management - Maintain supplier/vendor qualification schedule and the Approved Supplier List for GMP and GCP suppliers and vendor. Track the status approval status and expiration of supplier Quality Agreements and notify Quality management of upcoming expirations.
  
  
  •Product Quality Complaints - Maintain electronic trackers of product complaints. Coordinate with client Chemistry, Manufacturing and Controls (CMC) and Clinical Supply team to collect complaint documentation. Ensure that electronic folders housing complaint documentation are complete.
  
  
  •Internal Audits - Assist in conducting internal audits of client quality systems and records. Maintain the internal audit schedule and audit records.
  
  
  •Other Duties - Other Quality Assurance tasks may be assigned by Quality management as needed.
  
  

Qualifications & Requirements:

• • Bachelor's degree preferably in a scientific or technical discipline; advanced degree preferred.
  
  • Minimum 5 years of experience in analytical chemistry methods with preference for nasal spray experience, analytical method validation, stability data review, and out of specification investigations.
  
  • 2+ years of experience with the Veeva Quality Docs platform.
  
  • Experience with DocuSign Part 11.
  
  • Experience with data storage platforms such as Box GxP.
  
  • Experience using Microsoft Excel and Word.
  
  • Strong team player that has a customer service approach and is solution oriented.
  
  

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.



Contact: anarayan@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now