On-site in Vacaville, CA

Summary:

• We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team. In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring compliance with cGMP and global requirements.

Key Responsibilities:

• Support the implementation, execution and maintenance of the PQS integration and Quality Documents in Veeva at the site.
• Support PQS integration by working with the Quality Document control group to complete workflows, document gating and coordinate elements of the document change process to ensure minimal disruption to site operations
• Support Quality Documents by:
• Initiating and management of documents in Veeva Quality Docs.
• Formatting and editing of control documents.
• Track and log request of source documents.
• Ensure all activities are conducted in compliance with cGMP and global requirements.
• Strive to maintain the highest level of inspection readiness at all times.

Key Requirements:

• 1-3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry, preferably within a supplier quality function.
• Ability to effectively collaborate within a diverse, cross-functional team.
• On-site presence at the Vacaville location is required.
• Preferred experience with Veeva Quality Document Management System and Microsoft Teams.
• Preferred Technical writing experience.

The hiring range for this position is $25.00-$28.00 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.