Kelly® Science & Clinical is seeking a Quality Assurance Associate for a permanent position at a remote client. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary/Pay Rate/Compensation: $105k-130k annually

Overview
This client is an industry-leading company focused on GxP operations. 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 the client’s Quality Systems and Records.

Schedule:
This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Senior Manager, Quality Assurance.

Responsibilities:

• 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 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 consultants for new and revised standard operating procedures 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, and follow-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 the client’s 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 vendors. 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 the client’s 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 the client’s 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:

• 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.
  

• Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  

• Strong written and verbal communication and presentation skills.
  

• Ability to work independently in a remote setting.

What happens next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
 

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