Specialist, Quality Assurance -Change Control

Sagent Pharmaceuticals - Schaumburg, IL

Quality Assurance Specialist, Change Control

Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.

This role is responsible for the support and approval of change controls for all labeling and external changes involving our Contract Manufacturing Organizations (CMO). Work in partnership with Regulatory Affairs, Global Alliance Management, Labeling and CMOs to ensure Sagent’s requirements for changes are met in accordance with FDA requirements. Support the existing Quality Management System (QMS) including executing SOPs and data management.

You will be working with on time releases and launches as it relates to change controls, measurement of regulatory action against Sagent as relates to labeling or external change controls and data management supporting our QMS.

This person will be expected to:

• Review and provide QA approval for external and label changes performed by Sagent’s CMOs
• Review associated documentation for external changes such as finished product specifications, batch records, packaging specification sheets and testing specifications
• Responsible for QA functions of the labeling and external change control processes within the TrackWise system
• Review and provide QA approval for labeling/packaging components.
• Ensures cGMP compliance and accuracy in comparison to the Reference Listed Drug (RLD)
• Provide guidance and support in all aspects of cGMP to our CMOs, including good documentation practices
• Ensure all applicable data is accurate, up to date, and defendable to regulatory authorities
• Provide ongoing support to the existing Quality Management System and training programs
• Write, review, or implement new standard operating procedures and policies, as necessary
• Participate on Global Alliance Management project teams to communicate quality concerns and team progress
• Elevates issues to upper management as needed
• Other responsibilities as necessary to support Sagent business

Candidate Qualifications:

• Bachelor’s degree in Scientific related field
• 3+ years of experience in a Quality related position and knowledge of GMP, GLP and FDA trends
• TrackWise software experience preferred
• Must have excellent organizational and project management skills to coordinate multiple projects
• Strong interpersonal communication skills required – verbal, written and presentation

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