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Quality Systems Specialist

Application Deadline: June 2, 2020

Location: Schaumburg, IL, United States

Job Summary / Overview:

Provide Quality Assurance support for lifecycle management of products marketed by Sagent.  Proactively support the existing quality systems as necessary including writing policies and procedures, change control of GMP documentation, training, customer complaint support, Annual Product Review, performing audits, and benchmarking cGMP requirements to ensure compliance with regulations.

Key Duties & Responsibilities:

  • Annual Product Review – Review, compile, track and trend information in support of Annual Product Reviews for Sagent products. Includes communication with internal departments and external CMO to assemble the required APR information.  Collect data in support of partner Annual Product Review reports.

  • Customer Complaints: Manage the complaint program by collecting information from customers, coordinating investigations with Contact Manufacturing Organizations, writing investigations, and entering information into the TrackWise®

  • Field Alert and Recall: Gather information and support investigations in support of required Field Alerts and Recalls.

  • Document Change Control: Coordinate the processing and maintenance of policies and procedures for company compliance with regulations. Assist with creation and routing of changes in Veeva Vault.

  • Training: Distribute new/revised procedures for training. Ensure employees complete training on-time. Manage electronic Learning Management System.

  • Management Review: Support the Management Review process by compiling, and trending quality data.

  • Supplier Audit:

    • Monitoring of audits from outside vendor: scheduling audits, pre-audit call, review audit reports, download audit records from vendor database

    • Report audit findings to suppliers, monitor supplier responses and corrective action objective evidence

    • Enter audit findings and supplier responses in TrackWise

    • Perform selected domestic supplier audits

  • Quality Agreements: Route Quality Agreements for approval

  • IT Quality Systems: Business Owner & Subject Matter Expert for TrackWise, Veeva Vault, and ComplianceWire systems

  • Internal Audit: Perform Sagent Internal Audits (5-6 per year)

  • Regulatory Inspections: Subject matter expert and audit administration during FDA inspections


  • Bachelor of Science degree in Chemistry, Biology, Pharmacy, or related science field

  • 3 - 5 years of progressive challenging QA/QC experience in the pharmaceutical or related industry

  • In-depth knowledge of current GMP and GLP as well as FDA trends and guidelines

  • Strong writing skills to create various Quality Systems documents/records

  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective

  • Organizational and project management skills to support quality improvement projects

  • Minimal travel (less than 10%)

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

No Relocation will be provided for this role.

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